Trial Outcomes & Findings for Study of BPZE1 (High Dose) Nasal Live Attenuated B. Pertussis Vaccine (NCT NCT02453048)
NCT ID: NCT02453048
Last Updated: 2020-01-02
Results Overview
Percentage is based on subjects experiencing at least one of the following events: * Cough and spasmodic cough of grade 2 or higher * Other respiratory tract AE related or possibly related to vaccination of grade 3 or higher * Any other AE related or possibly related to vaccination of grade 3 or higher
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
54 participants
Primary outcome timeframe
28 days
Results posted on
2020-01-02
Participant Flow
Participant milestones
| Measure |
Placebo
Individuals will be vaccinated once intranasally with the designated dose of Placebo at a Dose 2 x 0.4 mL (0.4 mL per nostril).
Placebo: Diluent
|
BPZE1 - 10,000,000 Cfu
Individuals will be vaccinated once intranasally with the designated dose of BPZE1 at a Dose 2 x 0.4 mL (0.4 mL per nostril).
BPZE1: Intranasal live, attenuated vaccine
|
BPZE1 - 100,000,000 Cfu
Individuals will be vaccinated once intranasally with the designated dose of BPZE1 at a Dose 2 x 0.4 mL (0.4 mL per nostril).
BPZE1: Intranasal live, attenuated vaccine
|
BPZE1 - 1,000,000,000 Cfu
Individuals will be vaccinated once intranasally with the designated dose of BPZE1 at a Dose 2 x 0.4 mL (0.4 mL per nostril).
BPZE1: Intranasal live, attenuated vaccine
|
BPZE1 - High Antibody 1,000,000,000 Cfu
Individuals with high baseline antibodies will be vaccinated once intranasally with the designated dose of BPZE1 at a Dose 2 x 0.4 mL (0.4 mL per nostril).
BPZE1: Intranasal live, attenuated vaccine
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
12
|
6
|
|
Overall Study
6-month Follow-up
|
12
|
12
|
12
|
12
|
6
|
|
Overall Study
COMPLETED
|
12
|
11
|
10
|
12
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
0
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Individuals will be vaccinated once intranasally with the designated dose of Placebo at a Dose 2 x 0.4 mL (0.4 mL per nostril).
Placebo: Diluent
|
BPZE1 - 10,000,000 Cfu
Individuals will be vaccinated once intranasally with the designated dose of BPZE1 at a Dose 2 x 0.4 mL (0.4 mL per nostril).
BPZE1: Intranasal live, attenuated vaccine
|
BPZE1 - 100,000,000 Cfu
Individuals will be vaccinated once intranasally with the designated dose of BPZE1 at a Dose 2 x 0.4 mL (0.4 mL per nostril).
BPZE1: Intranasal live, attenuated vaccine
|
BPZE1 - 1,000,000,000 Cfu
Individuals will be vaccinated once intranasally with the designated dose of BPZE1 at a Dose 2 x 0.4 mL (0.4 mL per nostril).
BPZE1: Intranasal live, attenuated vaccine
|
BPZE1 - High Antibody 1,000,000,000 Cfu
Individuals with high baseline antibodies will be vaccinated once intranasally with the designated dose of BPZE1 at a Dose 2 x 0.4 mL (0.4 mL per nostril).
BPZE1: Intranasal live, attenuated vaccine
|
|---|---|---|---|---|---|
|
Overall Study
Only part of initial 6 mo. study
|
0
|
0
|
0
|
0
|
6
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
2
|
0
|
0
|
Baseline Characteristics
Study of BPZE1 (High Dose) Nasal Live Attenuated B. Pertussis Vaccine
Baseline characteristics by cohort
| Measure |
Placebo
n=12 Participants
Individuals will be vaccinated once intranasally with the designated dose of Placebo at a Dose 2 x 0.4 mL (0.4 mL per nostril).
Placebo: Diluent
|
BPZE1 - 10,000,000 Cfu
n=12 Participants
Individuals will be vaccinated once intranasally with the designated dose of BPZE1 at a Dose 2 x 0.4 mL (0.4 mL per nostril).
BPZE1: Intranasal live, attenuated vaccine
|
BPZE1 - 100,000,000 Cfu
n=12 Participants
Individuals will be vaccinated once intranasally with the designated dose of BPZE1 at a Dose 2 x 0.4 mL (0.4 mL per nostril).
BPZE1: Intranasal live, attenuated vaccine
|
BPZE1 - 1,000,000,000 Cfu
n=12 Participants
Individuals will be vaccinated once intranasally with the designated dose of BPZE1 at a Dose 2 x 0.4 mL (0.4 mL per nostril).
BPZE1: Intranasal live, attenuated vaccine
|
BPZE1 - High Antibody 1,000,000,000 Cfu
n=6 Participants
Individuals with high baseline antibodies will be vaccinated once intranasally with the designated dose of BPZE1 at a Dose 2 x 0.4 mL (0.4 mL per nostril).
BPZE1: Intranasal live, attenuated vaccine
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
<20 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Age, Customized
20-25 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
|
Age, Customized
25-30 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
31 Participants
n=10 Participants
|
|
Age, Customized
>=30 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
33 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
54 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
Sweden
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
12 participants
n=4 Participants
|
6 participants
n=21 Participants
|
54 participants
n=10 Participants
|
|
Height
|
1.74 m
n=5 Participants
|
1.77 m
n=7 Participants
|
1.8 m
n=5 Participants
|
1.72 m
n=4 Participants
|
1.76 m
n=21 Participants
|
1.76 m
n=10 Participants
|
|
BMI
|
22 kg/m^2
n=5 Participants
|
22 kg/m^2
n=7 Participants
|
22 kg/m^2
n=5 Participants
|
23 kg/m^2
n=4 Participants
|
22 kg/m^2
n=21 Participants
|
22 kg/m^2
n=10 Participants
|
|
Weight
|
69 kg
n=5 Participants
|
71 kg
n=7 Participants
|
74 kg
n=5 Participants
|
69 kg
n=4 Participants
|
69 kg
n=21 Participants
|
70 kg
n=10 Participants
|
|
Oral Temperature
|
36.5 C
n=5 Participants
|
36.8 C
n=7 Participants
|
36.6 C
n=5 Participants
|
36.6 C
n=4 Participants
|
36.3 C
n=21 Participants
|
36.6 C
n=10 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Arms (Placebo separated from randomized groups)
Percentage is based on subjects experiencing at least one of the following events: * Cough and spasmodic cough of grade 2 or higher * Other respiratory tract AE related or possibly related to vaccination of grade 3 or higher * Any other AE related or possibly related to vaccination of grade 3 or higher
Outcome measures
| Measure |
Placebo
n=12 Participants
Subjects receiving intranasal Placebo
|
Low Dose Group
n=12 Participants
Subjects receiving 10\^7 CFU of intranasal BPZE1
|
Medium Dose Group
n=12 Participants
Subjects receiving 10\^8 CFU of intranasal BPZE1
|
High Dose Group
n=12 Participants
Subjects receiving 10\^9 CFU of intranasal BPZE1
|
PRN High Group
n=6 Participants
Subjects with a pre-existing baseline PRN \> 20 IU that received 10\^9 CFU of intranasal BPZE1 (non-randomized group)
|
|---|---|---|---|---|---|
|
The Primary Safety Endpoint is the Number and Percentage of Participants Per Dose Group and Randomized Allocation, With at Least One of the Following Adverse Events Between Day 0 and Day 28
Other AE grade >=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Primary Safety Endpoint is the Number and Percentage of Participants Per Dose Group and Randomized Allocation, With at Least One of the Following Adverse Events Between Day 0 and Day 28
Cough or Spasmodic Cough of grade >=2
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
The Primary Safety Endpoint is the Number and Percentage of Participants Per Dose Group and Randomized Allocation, With at Least One of the Following Adverse Events Between Day 0 and Day 28
Other respiratory tract AE of grade >=3
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 daysTo assess the proportion of subjects having positive colonization of the human respiratory tract by live attenuated B. pertussis strain BPZE1 per group at any time period measured at 4, 7, 11, 14, 21 and 28 days post vaccination.
Outcome measures
| Measure |
Placebo
n=12 Participants
Subjects receiving intranasal Placebo
|
Low Dose Group
n=12 Participants
Subjects receiving 10\^7 CFU of intranasal BPZE1
|
Medium Dose Group
n=12 Participants
Subjects receiving 10\^8 CFU of intranasal BPZE1
|
High Dose Group
n=12 Participants
Subjects receiving 10\^9 CFU of intranasal BPZE1
|
PRN High Group
n=6 Participants
Subjects with a pre-existing baseline PRN \> 20 IU that received 10\^9 CFU of intranasal BPZE1 (non-randomized group)
|
|---|---|---|---|---|---|
|
Proportion of Subjects With BPZE1 Colonization
Colonized
|
0 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
2 Participants
|
|
Proportion of Subjects With BPZE1 Colonization
Not Colonized
|
12 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 6 monthsTo assess the number of immune responders and levels of Immunoglobulin G/Immunoglobulin A (IgG/IgA) antibodies to pertussis toxin (PT), filamentous haemagglutinin adhesin (FHA), Pertactin (PRN), and fimbriae 2/3 in serum and nasopharyngeal aspirate. A positive antibody response after vaccination is defined as at least 100% increase from pre- to post-vaccination, to at least 4 times minimum level of detection (MLD) for PT, FHA, PRN, and fimbriae 2/3 in the post-vaccination sample. The 4 antigens described are the standard 4 antigens historically used to describe a serum immunological response to B. pertussis. The absolute serum antibody titers have not shown a correlation of protection in previous pertussis vaccine studies of the current acellular vaccine and there is no known serum antigen threshold of protection for pertussis. Antibodies are measured before vaccination and at 4, 7, 11, 14, 21, 28 days, 6-months and 12-months post-vaccination.
Outcome measures
| Measure |
Placebo
n=12 Participants
Subjects receiving intranasal Placebo
|
Low Dose Group
n=12 Participants
Subjects receiving 10\^7 CFU of intranasal BPZE1
|
Medium Dose Group
n=12 Participants
Subjects receiving 10\^8 CFU of intranasal BPZE1
|
High Dose Group
n=12 Participants
Subjects receiving 10\^9 CFU of intranasal BPZE1
|
PRN High Group
n=6 Participants
Subjects with a pre-existing baseline PRN \> 20 IU that received 10\^9 CFU of intranasal BPZE1 (non-randomized group)
|
|---|---|---|---|---|---|
|
The Proportion of Subjects That Have an Antibody Response to BPZE1 Vaccination
IgG Response · Non-responding Subjects
|
11 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
|
The Proportion of Subjects That Have an Antibody Response to BPZE1 Vaccination
IgG Response · 1 Antigen
|
1 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
The Proportion of Subjects That Have an Antibody Response to BPZE1 Vaccination
IgG Response · 2 Antigens
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
The Proportion of Subjects That Have an Antibody Response to BPZE1 Vaccination
IgG Response · 3 Antigens
|
0 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
The Proportion of Subjects That Have an Antibody Response to BPZE1 Vaccination
IgG Response · 4 Antigens
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
The Proportion of Subjects That Have an Antibody Response to BPZE1 Vaccination
IgA Response · Non-responding Subjects
|
10 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
|
The Proportion of Subjects That Have an Antibody Response to BPZE1 Vaccination
IgA Response · 1 Antigen
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
The Proportion of Subjects That Have an Antibody Response to BPZE1 Vaccination
IgA Response · 2 Antigens
|
0 Participants
|
3 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
|
The Proportion of Subjects That Have an Antibody Response to BPZE1 Vaccination
IgA Response · 3 Antigens
|
0 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
|
The Proportion of Subjects That Have an Antibody Response to BPZE1 Vaccination
IgA Response · 4 Antigens
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Proportion of Subjects That Have an Antibody Response to BPZE1 Vaccination
IgG or IgA Response · Non-responding Subjects
|
10 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
|
The Proportion of Subjects That Have an Antibody Response to BPZE1 Vaccination
IgG or IgA Response · 1 Antigen
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
The Proportion of Subjects That Have an Antibody Response to BPZE1 Vaccination
IgG or IgA Response · 2 Antigens
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
|
The Proportion of Subjects That Have an Antibody Response to BPZE1 Vaccination
IgG or IgA Response · 3 Antigens
|
0 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
|
The Proportion of Subjects That Have an Antibody Response to BPZE1 Vaccination
IgG or IgA Response · 4 Antigens
|
0 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Low Dose Group
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Medium Dose Group
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
High Dose Group
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
PRN High Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=12 participants at risk
Subjects receiving intranasal Placebo
|
Low Dose Group
n=12 participants at risk
Subjects receiving 10\^7 CFU of intranasal BPZE1
|
Medium Dose Group
n=12 participants at risk
Subjects receiving 10\^8 CFU of intranasal BPZE1
|
High Dose Group
n=12 participants at risk
Subjects receiving 10\^9 CFU of intranasal BPZE1
|
PRN High Group
n=6 participants at risk
Subjects with a pre-existing baseline PRN \> 20 IU that received 10\^9 CFU of intranasal BPZE1 (non-randomized group)
|
|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
8.3%
1/12 • Number of events 1 • 14 days, 1 month, 3 months, 6 months, 1 year
|
0.00%
0/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
0.00%
0/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
0.00%
0/6 • 14 days, 1 month, 3 months, 6 months, 1 year
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
0.00%
0/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
8.3%
1/12 • Number of events 1 • 14 days, 1 month, 3 months, 6 months, 1 year
|
0.00%
0/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
0.00%
0/6 • 14 days, 1 month, 3 months, 6 months, 1 year
|
Other adverse events
| Measure |
Placebo
n=12 participants at risk
Subjects receiving intranasal Placebo
|
Low Dose Group
n=12 participants at risk
Subjects receiving 10\^7 CFU of intranasal BPZE1
|
Medium Dose Group
n=12 participants at risk
Subjects receiving 10\^8 CFU of intranasal BPZE1
|
High Dose Group
n=12 participants at risk
Subjects receiving 10\^9 CFU of intranasal BPZE1
|
PRN High Group
n=6 participants at risk
Subjects with a pre-existing baseline PRN \> 20 IU that received 10\^9 CFU of intranasal BPZE1 (non-randomized group)
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough - week 1
|
16.7%
2/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
33.3%
4/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
25.0%
3/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
16.7%
2/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
16.7%
1/6 • 14 days, 1 month, 3 months, 6 months, 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough - week 2
|
8.3%
1/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
0.00%
0/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
16.7%
2/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
16.7%
2/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
0.00%
0/6 • 14 days, 1 month, 3 months, 6 months, 1 year
|
|
General disorders
Fatigue - week 1
|
50.0%
6/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
41.7%
5/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
50.0%
6/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
33.3%
4/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
66.7%
4/6 • 14 days, 1 month, 3 months, 6 months, 1 year
|
|
General disorders
Fatigue - Week 2
|
8.3%
1/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
16.7%
2/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
16.7%
2/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
8.3%
1/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
16.7%
1/6 • 14 days, 1 month, 3 months, 6 months, 1 year
|
|
Nervous system disorders
Headache - week 1
|
41.7%
5/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
16.7%
2/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
50.0%
6/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
25.0%
3/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
50.0%
3/6 • 14 days, 1 month, 3 months, 6 months, 1 year
|
|
Nervous system disorders
Headache - week 2
|
0.00%
0/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
16.7%
2/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
8.3%
1/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
25.0%
3/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
0.00%
0/6 • 14 days, 1 month, 3 months, 6 months, 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion - week 1
|
25.0%
3/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
50.0%
6/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
33.3%
4/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
16.7%
2/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
50.0%
3/6 • 14 days, 1 month, 3 months, 6 months, 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion - week 2
|
16.7%
2/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
0.00%
0/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
33.3%
4/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
0.00%
0/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
16.7%
1/6 • 14 days, 1 month, 3 months, 6 months, 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea - week 1
|
50.0%
6/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
41.7%
5/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
33.3%
4/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
25.0%
3/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
33.3%
2/6 • 14 days, 1 month, 3 months, 6 months, 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea - week 2
|
16.7%
2/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
8.3%
1/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
25.0%
3/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
8.3%
1/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
0.00%
0/6 • 14 days, 1 month, 3 months, 6 months, 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing - week 1
|
33.3%
4/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
58.3%
7/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
33.3%
4/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
50.0%
6/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
33.3%
2/6 • 14 days, 1 month, 3 months, 6 months, 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing - week 2
|
25.0%
3/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
25.0%
3/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
16.7%
2/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
25.0%
3/12 • 14 days, 1 month, 3 months, 6 months, 1 year
|
0.00%
0/6 • 14 days, 1 month, 3 months, 6 months, 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publications will be co-authored by the PI and the Sponsor (Inserm).
- Publication restrictions are in place
Restriction type: OTHER