Trial Outcomes & Findings for Dose Escalation PfSPZ-CVac (NCT NCT03083847)
NCT ID: NCT03083847
Last Updated: 2021-06-01
Results Overview
Participants with P. falciparum blood stage infection defined as detection of P. falciparum parasites by qPCR (real time NIH qPCR and sensitive retrospective Laboratory of Malaria Immunology \& Vaccinology (LMIV) qPCR) following Sanaria® PfSPZ Challenge (NF54) via direct venous injection (DVI).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
55 participants
Primary outcome timeframe
14 days post PfSPZ Challenge injection
Results posted on
2021-06-01
Participant Flow
Contingency arms for a higher PYR dose (75mg instead of 50mg) were not enrolled as criteria were not met for their inclusion (50mg of PYR prevented detectable parasitemia in all enrolled arms). The PYR contingency arms that were not enrolled were labelled 1c, 1e, and 1f in the protocol.
121 participants were screened; 55 participants were assigned to an arm; 66 participants did not meet screening criteria; one subject was consented to two arms, but started on only a control arm. Participants in each Pilot phase were independent; no participant was enrolled in more than one arm or period in either the pilot or main phases.
Participant milestones
| Measure |
Pilot (1a):1 Injection of 5x10^4 PfSPZ Challenge+Pyrimethamine
Pilot Phase - 1 injection of 5x10\^4 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
|
Pilot (1b):1 Injection of 1x10^5 PfSPZ Challenge+Pyrimethamine
Pilot Phase - 1 injection of 1x10\^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
|
Pilot (5a): 1 Injection of 1x10^5 PfSPZ Challenge+Chloroquine
Pilot Phase - 1 injection of 1x10\^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
|
Pilot (1d):1 Injection of 2x10^5 PfSPZ Challenge+Pyrimethamine
Pilot Phase - 1 injection of 2x10\^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
|
Pilot (5b): 1 Injection of 2x10^5 PfSPZ Challenge+Chloroquine
Pilot Phase - 1 injection of 2x10\^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
|
Main (2a):3 Doses of 2x10^5 PfSPZ Challenge+Pyrimethamine+NF54
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + homologous controlled human malaria infection (CHMI) with 3.2x10\^3 PfSPZ Challenge (NF54) at 12 weeks after third injection
|
Main (2b):3 Doses of 2x10^5 PfSPZ Challenge+Pyrimethamine+7G8
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + heterologous CHMI with 3.2x10\^3 PfSPZ Challenge (7G8) at 12 weeks after third injection
|
Main (3):3 Doses of 2x10^5 PfSPZ Challenge+Chloroquine+7G8
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + weekly chloroquine (1000mg given 2 days prior to injections and 500mg given 5 days post injection and weekly thereafter until 5 days post third injection) + heterologous controlled human malaria infection (CHMI) with 3.2x10\^3 PfSPZ Challenge (7G8) at 12 weeks after third injection
|
Main Phase (4a) - Infectivity Control: NF54 (Homologous) CHMI
Main Phase - Infectivity Control with one dose of 3.2x10\^3 sporozoites of PfSPZ Challenge (NF54) (homologous) controlled human malaria infection (CHMI)
|
Main Phase (4b) - Infectivity Control: 7G8 (Heterologous) CHMI
Main Phase - Infectivity Control with 3.2x10\^3 sporozoites of PfSPZ Challenge 7G8 (heterologous) controlled human malaria infection (CHMI)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pilot 1a
STARTED
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Pilot 1a
COMPLETED
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Pilot 1a
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Pilot Ib & 5a
STARTED
|
0
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Pilot Ib & 5a
COMPLETED
|
0
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Pilot Ib & 5a
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Pilot 1d & 5b
STARTED
|
0
|
0
|
0
|
4
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Pilot 1d & 5b
COMPLETED
|
0
|
0
|
0
|
4
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Pilot 1d & 5b
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main
STARTED
|
0
|
0
|
0
|
0
|
0
|
9
|
10
|
10
|
4
|
8
|
|
Main
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
8
|
9
|
6
|
4
|
8
|
|
Main
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
4
|
0
|
0
|
Reasons for withdrawal
| Measure |
Pilot (1a):1 Injection of 5x10^4 PfSPZ Challenge+Pyrimethamine
Pilot Phase - 1 injection of 5x10\^4 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
|
Pilot (1b):1 Injection of 1x10^5 PfSPZ Challenge+Pyrimethamine
Pilot Phase - 1 injection of 1x10\^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
|
Pilot (5a): 1 Injection of 1x10^5 PfSPZ Challenge+Chloroquine
Pilot Phase - 1 injection of 1x10\^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
|
Pilot (1d):1 Injection of 2x10^5 PfSPZ Challenge+Pyrimethamine
Pilot Phase - 1 injection of 2x10\^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
|
Pilot (5b): 1 Injection of 2x10^5 PfSPZ Challenge+Chloroquine
Pilot Phase - 1 injection of 2x10\^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
|
Main (2a):3 Doses of 2x10^5 PfSPZ Challenge+Pyrimethamine+NF54
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + homologous controlled human malaria infection (CHMI) with 3.2x10\^3 PfSPZ Challenge (NF54) at 12 weeks after third injection
|
Main (2b):3 Doses of 2x10^5 PfSPZ Challenge+Pyrimethamine+7G8
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + heterologous CHMI with 3.2x10\^3 PfSPZ Challenge (7G8) at 12 weeks after third injection
|
Main (3):3 Doses of 2x10^5 PfSPZ Challenge+Chloroquine+7G8
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + weekly chloroquine (1000mg given 2 days prior to injections and 500mg given 5 days post injection and weekly thereafter until 5 days post third injection) + heterologous controlled human malaria infection (CHMI) with 3.2x10\^3 PfSPZ Challenge (7G8) at 12 weeks after third injection
|
Main Phase (4a) - Infectivity Control: NF54 (Homologous) CHMI
Main Phase - Infectivity Control with one dose of 3.2x10\^3 sporozoites of PfSPZ Challenge (NF54) (homologous) controlled human malaria infection (CHMI)
|
Main Phase (4b) - Infectivity Control: 7G8 (Heterologous) CHMI
Main Phase - Infectivity Control with 3.2x10\^3 sporozoites of PfSPZ Challenge 7G8 (heterologous) controlled human malaria infection (CHMI)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Main
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Main
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Main
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Main
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Dose Escalation PfSPZ-CVac
Baseline characteristics by cohort
| Measure |
Main (2a):3 Doses of 2x10^5 PfSPZ Challenge+Pyrimethamine+NF54
n=9 Participants
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + homologous controlled human malaria infection (CHMI) with 3.2x10\^3 PfSPZ Challenge (NF54) at 12 weeks after third injection
|
Main (2b):3 Doses of 2x10^5 PfSPZ Challenge+Pyrimethamine+7G8
n=10 Participants
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + heterologous CHMI with 3.2x10\^3 PfSPZ Challenge (7G8) at 12 weeks after third injection
|
Main (3):3 Doses of 2x10^5 PfSPZ Challenge+Chloroquine+7G8
n=10 Participants
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + weekly chloroquine (1000mg given 2 days prior to injections and 500mg given 5 days post injection and weekly thereafter until 5 days post third injection) + heterologous controlled human malaria infection (CHMI) with 3.2x10\^3 PfSPZ Challenge (7G8) at 12 weeks after third injection
|
Main Phase (4a) - Infectivity Control: NF54 (Homologous) CHMI
n=4 Participants
Main Phase - Infectivity Control with one dose of 3.2x10\^3 sporozoites of PfSPZ Challenge (NF54) (homologous) controlled human malaria infection (CHMI)
|
Main Phase (4b) - Infectivity Control: 7G8 (Heterologous) CHMI
n=8 Participants
Main Phase - Infectivity Control with 3.2x10\^3 sporozoites of PfSPZ Challenge 7G8 (heterologous) controlled human malaria infection (CHMI)
|
Pilot (1a):1 Injection of 5x10^4 PfSPZ Challenge+Pyrimethamine
n=2 Participants
Pilot Phase - 1 injection of 5x10\^4 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
|
Pilot (1b):1 Injection of 1x10^5 PfSPZ Challenge+Pyrimethamine
n=2 Participants
Pilot Phase - 1 injection of 1x10\^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
|
Pilot (1d):1 Injection of 2x10^5 PfSPZ Challenge+Pyrimethamine
n=4 Participants
Pilot Phase - 1 injection of 2x10\^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
|
Pilot (5a): 1 Injection of 1x10^5 PfSPZ Challenge+Chloroquine
n=2 Participants
Pilot Phase - 1 injection of 1x10\^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
|
Pilot (5b): 1 Injection of 2x10^5 PfSPZ Challenge+Chloroquine
n=4 Participants
Pilot Phase - 1 injection of 2x10\^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=62 Participants
|
55 Participants
n=95 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
25 Participants
n=95 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=62 Participants
|
30 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
5 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=62 Participants
|
50 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
3 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
11 Participants
n=95 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=62 Participants
|
36 Participants
n=95 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
PRIMARY outcome
Timeframe: 14 days post PfSPZ Challenge injectionPopulation: Participants who received investigational product
Participants with P. falciparum blood stage infection defined as detection of P. falciparum parasites by qPCR (real time NIH qPCR and sensitive retrospective Laboratory of Malaria Immunology \& Vaccinology (LMIV) qPCR) following Sanaria® PfSPZ Challenge (NF54) via direct venous injection (DVI).
Outcome measures
| Measure |
Pilot (1a):1 Injection of 5x10^4 PfSPZ Challenge+Pyrimethamine
n=2 Participants
Pilot Phase - 1 injection of 5x10\^4 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection.
|
Pilot (1b): 1 Dose of 1x10^5 PfSPZ Challenge + Pyrimethamine
n=2 Participants
Pilot Phase - 1 injection of 1x10\^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection.
|
Pilot (1d): 1 Dose of 2x10^5 PfSPZ Challenge + Pyrimethamine
n=4 Participants
Pilot Phase - 1 injection of 2x10\^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection.
|
Main (2a): 3 Doses of 2x10^5 PfSPZ + Pyrimethamine + NF54 CHMI
n=9 Participants
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + homologous controlled human malaria infection (CHMI) with 3.2x10\^3 PfSPZ Challenge (NF54) at 12 weeks after third injection.
|
Main (2b): 3 Doses of 2x10^5 PfSPZ + Pyrimethamine + 7G8 CHMI
n=10 Participants
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + heterologous CHMI with 3.2x10\^3 PfSPZ Challenge (7G8) at 12 weeks after third injection.
|
Main (3):3 Doses of 2x10^5 PfSPZ Challenge+Chloroquine+7G8
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + weekly chloroquine (1000mg given 2 days prior to injections and 500mg given 5 days post injection and weekly thereafter until 5 days post third injection) + heterologous controlled human malaria infection (CHMI) with 3.2x10\^3 PfSPZ Challenge (7G8) at 12 weeks after third injection
|
Pilot (5a): 1 Injection of 1x10^5 PfSPZ Challenge+Chloroquine
Pilot Phase - 1 injection of 1x10\^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
|
Pilot (5b): 1 Injection of 2x10^5 PfSPZ Challenge+Chloroquine
Pilot Phase - 1 injection of 2x10\^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With P.Falciparum Blood Stage Infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 days post PfSPZ Challenge injectionIncidence of a clinical malaria diagnosis occurring after PfSPZ-Cvac challenge requiring treatment with atovaquone/proguanil (Malarone).
Outcome measures
| Measure |
Pilot (1a):1 Injection of 5x10^4 PfSPZ Challenge+Pyrimethamine
n=10 Participants
Pilot Phase - 1 injection of 5x10\^4 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection.
|
Pilot (1b): 1 Dose of 1x10^5 PfSPZ Challenge + Pyrimethamine
n=2 Participants
Pilot Phase - 1 injection of 1x10\^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection.
|
Pilot (1d): 1 Dose of 2x10^5 PfSPZ Challenge + Pyrimethamine
n=4 Participants
Pilot Phase - 1 injection of 2x10\^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection.
|
Main (2a): 3 Doses of 2x10^5 PfSPZ + Pyrimethamine + NF54 CHMI
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + homologous controlled human malaria infection (CHMI) with 3.2x10\^3 PfSPZ Challenge (NF54) at 12 weeks after third injection.
|
Main (2b): 3 Doses of 2x10^5 PfSPZ + Pyrimethamine + 7G8 CHMI
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + heterologous CHMI with 3.2x10\^3 PfSPZ Challenge (7G8) at 12 weeks after third injection.
|
Main (3):3 Doses of 2x10^5 PfSPZ Challenge+Chloroquine+7G8
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + weekly chloroquine (1000mg given 2 days prior to injections and 500mg given 5 days post injection and weekly thereafter until 5 days post third injection) + heterologous controlled human malaria infection (CHMI) with 3.2x10\^3 PfSPZ Challenge (7G8) at 12 weeks after third injection
|
Pilot (5a): 1 Injection of 1x10^5 PfSPZ Challenge+Chloroquine
Pilot Phase - 1 injection of 1x10\^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
|
Pilot (5b): 1 Injection of 2x10^5 PfSPZ Challenge+Chloroquine
Pilot Phase - 1 injection of 2x10\^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Requiring Treatment With Additional Anti-malarial Medication
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 7 monthsParticipants who had one or more episodes of related or/and unrelated adverse events (AEs). An AE is defined as any untoward medical occurrence temporarily associated with the subject's participation in research, whether or not considered related or not. Refer to adverse event table for specific AE.
Outcome measures
| Measure |
Pilot (1a):1 Injection of 5x10^4 PfSPZ Challenge+Pyrimethamine
n=2 Participants
Pilot Phase - 1 injection of 5x10\^4 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection.
|
Pilot (1b): 1 Dose of 1x10^5 PfSPZ Challenge + Pyrimethamine
n=2 Participants
Pilot Phase - 1 injection of 1x10\^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection.
|
Pilot (1d): 1 Dose of 2x10^5 PfSPZ Challenge + Pyrimethamine
n=4 Participants
Pilot Phase - 1 injection of 2x10\^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection.
|
Main (2a): 3 Doses of 2x10^5 PfSPZ + Pyrimethamine + NF54 CHMI
n=9 Participants
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + homologous controlled human malaria infection (CHMI) with 3.2x10\^3 PfSPZ Challenge (NF54) at 12 weeks after third injection.
|
Main (2b): 3 Doses of 2x10^5 PfSPZ + Pyrimethamine + 7G8 CHMI
n=10 Participants
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + heterologous CHMI with 3.2x10\^3 PfSPZ Challenge (7G8) at 12 weeks after third injection.
|
Main (3):3 Doses of 2x10^5 PfSPZ Challenge+Chloroquine+7G8
n=10 Participants
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + weekly chloroquine (1000mg given 2 days prior to injections and 500mg given 5 days post injection and weekly thereafter until 5 days post third injection) + heterologous controlled human malaria infection (CHMI) with 3.2x10\^3 PfSPZ Challenge (7G8) at 12 weeks after third injection
|
Pilot (5a): 1 Injection of 1x10^5 PfSPZ Challenge+Chloroquine
n=2 Participants
Pilot Phase - 1 injection of 1x10\^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
|
Pilot (5b): 1 Injection of 2x10^5 PfSPZ Challenge+Chloroquine
n=4 Participants
Pilot Phase - 1 injection of 2x10\^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Local and Systemic Adverse Events (AEs)
|
2 participants
|
2 participants
|
3 participants
|
8 participants
|
9 participants
|
10 participants
|
2 participants
|
4 participants
|
PRIMARY outcome
Timeframe: 7 monthsParticipants who had one or more episodes of serious adverse events (SAEs). SAE is defined as a life-threatening reaction or event that results in death.
Outcome measures
| Measure |
Pilot (1a):1 Injection of 5x10^4 PfSPZ Challenge+Pyrimethamine
n=2 Participants
Pilot Phase - 1 injection of 5x10\^4 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection.
|
Pilot (1b): 1 Dose of 1x10^5 PfSPZ Challenge + Pyrimethamine
n=2 Participants
Pilot Phase - 1 injection of 1x10\^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection.
|
Pilot (1d): 1 Dose of 2x10^5 PfSPZ Challenge + Pyrimethamine
n=4 Participants
Pilot Phase - 1 injection of 2x10\^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection.
|
Main (2a): 3 Doses of 2x10^5 PfSPZ + Pyrimethamine + NF54 CHMI
n=9 Participants
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + homologous controlled human malaria infection (CHMI) with 3.2x10\^3 PfSPZ Challenge (NF54) at 12 weeks after third injection.
|
Main (2b): 3 Doses of 2x10^5 PfSPZ + Pyrimethamine + 7G8 CHMI
n=10 Participants
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + heterologous CHMI with 3.2x10\^3 PfSPZ Challenge (7G8) at 12 weeks after third injection.
|
Main (3):3 Doses of 2x10^5 PfSPZ Challenge+Chloroquine+7G8
n=10 Participants
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + weekly chloroquine (1000mg given 2 days prior to injections and 500mg given 5 days post injection and weekly thereafter until 5 days post third injection) + heterologous controlled human malaria infection (CHMI) with 3.2x10\^3 PfSPZ Challenge (7G8) at 12 weeks after third injection
|
Pilot (5a): 1 Injection of 1x10^5 PfSPZ Challenge+Chloroquine
n=2 Participants
Pilot Phase - 1 injection of 1x10\^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
|
Pilot (5b): 1 Injection of 2x10^5 PfSPZ Challenge+Chloroquine
n=4 Participants
Pilot Phase - 1 injection of 2x10\^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
Adverse Events
Pilot (1a):1 Injection of 5x10^4 PfSPZ Challenge+Pyrimethamine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Pilot (1b):1 Injection of 1x10^5 PfSPZ Challenge+Pyrimethamine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Pilot (1d):1 Injection of 2x10^5 PfSPZ Challenge+Pyrimethamine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Pilot (5a): 1 Injection of 1x10^5 PfSPZ Challenge+Chloroquine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Pilot (5b): 1 Injection of 2x10^5 PfSPZ Challenge+Chloroquine
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Main (2a):3 Doses of 2x10^5 PfSPZ Challenge+Pyrimethamine+NF54
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Main (2b):3 Doses of 2x10^5 PfSPZ Challenge+Pyrimethamine+7G8
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Main (3):3 Doses of 2x10^5 PfSPZ Challenge+Chloroquine+7G8
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Main Phase (4a) - Infectivity Control: NF54 (Homologous) CHMI
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Main Phase (4b) - Infectivity Control: 7G8 (Heterologous) CHMI
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pilot (1a):1 Injection of 5x10^4 PfSPZ Challenge+Pyrimethamine
n=2 participants at risk
Pilot Phase - 1 injection of 5x10\^4 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
|
Pilot (1b):1 Injection of 1x10^5 PfSPZ Challenge+Pyrimethamine
n=2 participants at risk
Pilot Phase - 1 injection of 1x10\^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
|
Pilot (1d):1 Injection of 2x10^5 PfSPZ Challenge+Pyrimethamine
n=4 participants at risk
Pilot Phase - 1 injection of 2x10\^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
|
Pilot (5a): 1 Injection of 1x10^5 PfSPZ Challenge+Chloroquine
n=2 participants at risk
Pilot Phase - 1 injection of 1x10\^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
|
Pilot (5b): 1 Injection of 2x10^5 PfSPZ Challenge+Chloroquine
n=4 participants at risk
Pilot Phase - 1 injection of 2x10\^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
|
Main (2a):3 Doses of 2x10^5 PfSPZ Challenge+Pyrimethamine+NF54
n=9 participants at risk
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + homologous controlled human malaria infection (CHMI) with 3.2x10\^3 PfSPZ Challenge (NF54) at 12 weeks after third injection
|
Main (2b):3 Doses of 2x10^5 PfSPZ Challenge+Pyrimethamine+7G8
n=10 participants at risk
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + heterologous CHMI with 3.2x10\^3 PfSPZ Challenge (7G8) at 12 weeks after third injection
|
Main (3):3 Doses of 2x10^5 PfSPZ Challenge+Chloroquine+7G8
n=10 participants at risk
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + weekly chloroquine (1000mg given 2 days prior to injections and 500mg given 5 days post injection and weekly thereafter until 5 days post third injection) + heterologous controlled human malaria infection (CHMI) with 3.2x10\^3 PfSPZ Challenge (7G8) at 12 weeks after third injection
|
Main Phase (4a) - Infectivity Control: NF54 (Homologous) CHMI
n=4 participants at risk
Main Phase - Infectivity Control with one dose of 3.2x10\^3 sporozoites of PfSPZ Challenge (NF54) (homologous) controlled human malaria infection (CHMI)
|
Main Phase (4b) - Infectivity Control: 7G8 (Heterologous) CHMI
n=8 participants at risk
Main Phase - Infectivity Control with 3.2x10\^3 sporozoites of PfSPZ Challenge 7G8 (heterologous) controlled human malaria infection (CHMI)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
Other adverse events
| Measure |
Pilot (1a):1 Injection of 5x10^4 PfSPZ Challenge+Pyrimethamine
n=2 participants at risk
Pilot Phase - 1 injection of 5x10\^4 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
|
Pilot (1b):1 Injection of 1x10^5 PfSPZ Challenge+Pyrimethamine
n=2 participants at risk
Pilot Phase - 1 injection of 1x10\^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
|
Pilot (1d):1 Injection of 2x10^5 PfSPZ Challenge+Pyrimethamine
n=4 participants at risk
Pilot Phase - 1 injection of 2x10\^5 sporozoites of PfSPZ Challenge (NF54) with 50mg of pyrimethamine dosed on days 2 and 3 after injection
|
Pilot (5a): 1 Injection of 1x10^5 PfSPZ Challenge+Chloroquine
n=2 participants at risk
Pilot Phase - 1 injection of 1x10\^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
|
Pilot (5b): 1 Injection of 2x10^5 PfSPZ Challenge+Chloroquine
n=4 participants at risk
Pilot Phase - 1 injection of 2x10\^5 sporozoites of PfSPZ Challenge (NF54) with 1000mg of chloroquine (loading dose) 2 days prior to injections and 500mg (maintenance dose) 5 days post injection
|
Main (2a):3 Doses of 2x10^5 PfSPZ Challenge+Pyrimethamine+NF54
n=9 participants at risk
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + homologous controlled human malaria infection (CHMI) with 3.2x10\^3 PfSPZ Challenge (NF54) at 12 weeks after third injection
|
Main (2b):3 Doses of 2x10^5 PfSPZ Challenge+Pyrimethamine+7G8
n=10 participants at risk
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + pyrimethamine on days 2 and 3 post injection + heterologous CHMI with 3.2x10\^3 PfSPZ Challenge (7G8) at 12 weeks after third injection
|
Main (3):3 Doses of 2x10^5 PfSPZ Challenge+Chloroquine+7G8
n=10 participants at risk
Main Phase - 3 monthly doses of 2x10\^5 sporozoites of PfSPZ Challenge + weekly chloroquine (1000mg given 2 days prior to injections and 500mg given 5 days post injection and weekly thereafter until 5 days post third injection) + heterologous controlled human malaria infection (CHMI) with 3.2x10\^3 PfSPZ Challenge (7G8) at 12 weeks after third injection
|
Main Phase (4a) - Infectivity Control: NF54 (Homologous) CHMI
n=4 participants at risk
Main Phase - Infectivity Control with one dose of 3.2x10\^3 sporozoites of PfSPZ Challenge (NF54) (homologous) controlled human malaria infection (CHMI)
|
Main Phase (4b) - Infectivity Control: 7G8 (Heterologous) CHMI
n=8 participants at risk
Main Phase - Infectivity Control with 3.2x10\^3 sporozoites of PfSPZ Challenge 7G8 (heterologous) controlled human malaria infection (CHMI)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
22.2%
2/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
20.0%
2/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
12.5%
1/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
11.1%
1/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
20.0%
2/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Eye disorders
Photophobia
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
33.3%
3/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
30.0%
3/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
20.0%
2/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
50.0%
2/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
50.0%
1/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
11.1%
1/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
50.0%
1/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
22.2%
2/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
40.0%
4/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
11.1%
1/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
11.1%
1/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
50.0%
1/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
66.7%
6/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
40.0%
4/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
40.0%
4/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
2/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
General disorders
Chest pain
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
General disorders
Chills
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
50.0%
1/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
75.0%
3/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
20.0%
2/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
40.0%
4/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
12.5%
1/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
General disorders
Fatigue
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
50.0%
1/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
44.4%
4/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
70.0%
7/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
60.0%
6/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
75.0%
3/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
62.5%
5/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
General disorders
Feeling hot
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
General disorders
Injection site erythema
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
General disorders
Injection site induration
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
General disorders
Injection site pain
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
22.2%
2/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
General disorders
Injection site pruritus
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
11.1%
1/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
20.0%
2/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
General disorders
Malaise
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
50.0%
1/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
50.0%
1/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
12.5%
1/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
General disorders
Pain
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
General disorders
Pyrexia
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
50.0%
1/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
75.0%
3/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
11.1%
1/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
30.0%
3/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
40.0%
4/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
50.0%
1/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
50.0%
1/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
33.3%
3/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
12.5%
1/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
22.2%
2/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
20.0%
2/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Infections and infestations
Hordeolum
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Infections and infestations
Malaria
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
11.1%
1/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
100.0%
4/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
100.0%
8/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Infections and infestations
Otitis media
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
50.0%
1/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
33.3%
3/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
60.0%
6/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
40.0%
4/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
2/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
12.5%
1/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
30.0%
3/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
50.0%
1/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
50.0%
1/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
50.0%
2/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
11.1%
1/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
12.5%
1/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
20.0%
2/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Investigations
Blood pressure increased
|
50.0%
1/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
11.1%
1/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
11.1%
1/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
20.0%
2/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
40.0%
4/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
37.5%
3/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
50.0%
1/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
50.0%
2/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
20.0%
2/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
12.5%
1/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
50.0%
1/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
20.0%
2/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
30.0%
3/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
2/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Investigations
Smear cervix abnormal
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
22.2%
2/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Investigations
Weight decreased
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Investigations
White blood cell count decreased
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
20.0%
2/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
30.0%
3/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
12.5%
1/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Investigations
White blood cell count increased
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
50.0%
1/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
11.1%
1/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
30.0%
3/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
11.1%
1/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
33.3%
3/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
20.0%
2/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
40.0%
4/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
12.5%
1/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
50.0%
1/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
75.0%
3/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
33.3%
3/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
11.1%
1/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
1/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
50.0%
1/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
75.0%
3/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
55.6%
5/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
50.0%
5/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
60.0%
6/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
37.5%
3/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
12.5%
1/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
11.1%
1/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
30.0%
3/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
12.5%
1/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
100.0%
2/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
75.0%
3/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
33.3%
3/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
80.0%
8/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
70.0%
7/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
75.0%
3/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
12.5%
1/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
50.0%
1/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Nervous system disorders
Presyncope
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Nervous system disorders
Syncope
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
11.1%
1/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
100.0%
2/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
11.1%
1/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
11.1%
1/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
50.0%
1/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
20.0%
2/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
20.0%
2/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
12.5%
1/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
50.0%
1/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
33.3%
3/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
11.1%
1/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
30.0%
3/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
12.5%
1/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
11.1%
1/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
11.1%
1/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
11.1%
1/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
25.0%
1/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
22.2%
2/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
20.0%
2/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
|
Social circumstances
Alcohol use
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/2 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/9 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
10.0%
1/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/10 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
0.00%
0/4 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
12.5%
1/8 • Two weeks for pilot phase; four weeks for infectivity controls; seven months for main phase
|
Additional Information
Patrick Duffy
National Institute of Allergy and Infectious Diseases
Phone: (301) 761-5089
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place