Trial Outcomes & Findings for Safety and Dose Ranging Study of Acellular Pertussis and Acellular Pertussis -Tetanus-Diphtheria Booster Vaccines in Healthy Adults Ages 18 to 40 Years (NCT NCT01529645)
NCT ID: NCT01529645
Last Updated: 2016-04-04
Results Overview
The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
420 participants
Primary outcome timeframe
Day 30 post vaccination/baseline (Day 1)
Results posted on
2016-04-04
Participant Flow
Participant milestones
| Measure |
Group aP1
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP2
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP4
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group T5D2aP1
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP2
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP4
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP1
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP2
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP4
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Licensed TdaP
Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
42
|
42
|
42
|
42
|
42
|
42
|
42
|
42
|
|
Overall Study
COMPLETED
|
40
|
41
|
40
|
40
|
40
|
41
|
40
|
42
|
41
|
42
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
2
|
2
|
1
|
2
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group aP1
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP2
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP4
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group T5D2aP1
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP2
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP4
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP1
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP2
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP4
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Licensed TdaP
Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
1
|
1
|
0
|
2
|
0
|
1
|
0
|
|
Overall Study
SAE - Premature contractions
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Dose Ranging Study of Acellular Pertussis and Acellular Pertussis -Tetanus-Diphtheria Booster Vaccines in Healthy Adults Ages 18 to 40 Years
Baseline characteristics by cohort
| Measure |
Group aP1
n=42 Participants
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP2
n=42 Participants
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP4
n=42 Participants
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group T5D2aP1
n=42 Participants
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP2
n=42 Participants
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP4
n=42 Participants
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP1
n=42 Participants
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP2
n=42 Participants
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP4
n=42 Participants
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Licensed TdaP
n=42 Participants
Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
|
Total
n=420 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
26.6 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
26.8 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
27.4 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
26.8 years
STANDARD_DEVIATION 5.7 • n=4 Participants
|
27.7 years
STANDARD_DEVIATION 5.9 • n=21 Participants
|
25.8 years
STANDARD_DEVIATION 5.2 • n=8 Participants
|
25.1 years
STANDARD_DEVIATION 4.2 • n=8 Participants
|
27.5 years
STANDARD_DEVIATION 5.1 • n=24 Participants
|
27.2 years
STANDARD_DEVIATION 5.6 • n=42 Participants
|
27.4 years
STANDARD_DEVIATION 6.4 • n=42 Participants
|
26.8 years
STANDARD_DEVIATION 5.5 • n=42 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
27 Participants
n=42 Participants
|
24 Participants
n=42 Participants
|
250 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
23 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
170 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Day 1 through 7 after vaccinationPopulation: Analysis was done on the safety set, ie, all subjects who received the study vaccination and provided post vaccination safety data.
The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed and compared to that of licensed comparator in terms of the number of subjects reporting solicited local and systemic adverse events and other adverse events after vaccination.
Outcome measures
| Measure |
Group aP1
n=42 Participants
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP2
n=42 Participants
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP4
n=41 Participants
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group T5D2aP1
n=42 Participants
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP2
n=42 Participants
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP4
n=42 Participants
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP1
n=41 Participants
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP2
n=42 Participants
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP4
n=42 Participants
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Licensed TdaP
n=42 Participants
Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
Headache
|
17 participants
|
13 participants
|
12 participants
|
8 participants
|
13 participants
|
13 participants
|
16 participants
|
14 participants
|
17 participants
|
13 participants
|
|
The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
Any Other
|
6 participants
|
7 participants
|
2 participants
|
6 participants
|
8 participants
|
4 participants
|
8 participants
|
7 participants
|
7 participants
|
8 participants
|
|
The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
Body temperature (≥40°C)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
Prophylactic use of analgesic/antipyretic
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
1 participants
|
2 participants
|
1 participants
|
|
The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
Injection site erythema
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
6 participants
|
3 participants
|
2 participants
|
4 participants
|
3 participants
|
|
The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
Injection site induration
|
3 participants
|
3 participants
|
1 participants
|
6 participants
|
1 participants
|
7 participants
|
9 participants
|
4 participants
|
4 participants
|
6 participants
|
|
The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
Injection site pain
|
30 participants
|
32 participants
|
31 participants
|
35 participants
|
38 participants
|
36 participants
|
40 participants
|
35 participants
|
39 participants
|
31 participants
|
|
The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
Any Systemic
|
27 participants
|
20 participants
|
20 participants
|
18 participants
|
20 participants
|
23 participants
|
27 participants
|
21 participants
|
27 participants
|
21 participants
|
|
The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
Nausea
|
3 participants
|
6 participants
|
2 participants
|
1 participants
|
2 participants
|
5 participants
|
4 participants
|
6 participants
|
7 participants
|
1 participants
|
|
The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
Fatigue
|
19 participants
|
14 participants
|
13 participants
|
13 participants
|
15 participants
|
18 participants
|
20 participants
|
15 participants
|
16 participants
|
12 participants
|
|
The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
Generalized myalgia
|
10 participants
|
8 participants
|
4 participants
|
8 participants
|
10 participants
|
11 participants
|
12 participants
|
8 participants
|
9 participants
|
11 participants
|
|
The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
Generalized arthralgia
|
2 participants
|
0 participants
|
3 participants
|
4 participants
|
1 participants
|
3 participants
|
4 participants
|
4 participants
|
7 participants
|
1 participants
|
|
The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
Therapeutic use of analgesic/antipyretic
|
6 participants
|
7 participants
|
2 participants
|
6 participants
|
8 participants
|
3 participants
|
8 participants
|
7 participants
|
7 participants
|
8 participants
|
|
The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
Any local
|
30 participants
|
33 participants
|
32 participants
|
35 participants
|
38 participants
|
37 participants
|
40 participants
|
36 participants
|
39 participants
|
33 participants
|
|
The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
Injection site pruritus
|
0 participants
|
4 participants
|
1 participants
|
3 participants
|
2 participants
|
5 participants
|
3 participants
|
3 participants
|
6 participants
|
5 participants
|
PRIMARY outcome
Timeframe: From day 1 to day 365Population: Analysis was done on the safety set.
The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed in terms of the number of subjects reporting any unsolicited adverse events (AEs) between day 1 to day 30 , serious adverse events (SAEs) and AEs leading to premature withdrawal between day 1 to day 365, after vaccination.
Outcome measures
| Measure |
Group aP1
n=42 Participants
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP2
n=42 Participants
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP4
n=41 Participants
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group T5D2aP1
n=42 Participants
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP2
n=42 Participants
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP4
n=42 Participants
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP1
n=41 Participants
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP2
n=42 Participants
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP4
n=42 Participants
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Licensed TdaP
n=42 Participants
Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
Any AE (day 1 to 30)
|
20 participants
|
28 participants
|
12 participants
|
21 participants
|
13 participants
|
17 participants
|
16 participants
|
14 participants
|
18 participants
|
18 participants
|
|
The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
Any SAE (Day1 to Day 365)
|
4 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
2 participants
|
1 participants
|
|
The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
At least possibly related unsolicited AEs
|
11 participants
|
13 participants
|
7 participants
|
8 participants
|
9 participants
|
11 participants
|
7 participants
|
4 participants
|
11 participants
|
10 participants
|
|
The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
At least possibly related SAEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
AEs leading to withdrawal (Day1 to Day 365)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
Death
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 1 (baseline) and Day 30 post vaccinationPopulation: Analysis was done on the per-protocol population, ie, all subjects who correctly received the vaccine, and provided evaluable serum samples at the relevant time points and had no major protocol violation as defined prior to unblinding.
The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) on aP booster groups, against pertussis antigens pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), following vaccination with different antigenic formulations of aP versus the response to the commercially available comparator are reported.
Outcome measures
| Measure |
Group aP1
n=42 Participants
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP2
n=38 Participants
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP4
n=39 Participants
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group T5D2aP1
n=40 Participants
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP2
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP4
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP1
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP2
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP4
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Licensed TdaP
Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination
Day 1 (PT)
|
4.92 µg/mL
Interval 3.22 to 7.53
|
3.81 µg/mL
Interval 2.43 to 5.95
|
4.23 µg/mL
Interval 2.72 to 6.57
|
5.07 µg/mL
Interval 3.28 to 7.84
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination
Day 30 (PT; N= 39,35,36,40)
|
91 µg/mL
Interval 67.0 to 122.0
|
145 µg/mL
Interval 106.0 to 199.0
|
182 µg/mL
Interval 133.0 to 249.0
|
87 µg/mL
Interval 65.0 to 117.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination
Day 1 (FHA)
|
20 µg/mL
Interval 15.0 to 27.0
|
16 µg/mL
Interval 11.0 to 22.0
|
21 µg/mL
Interval 15.0 to 29.0
|
20 µg/mL
Interval 15.0 to 28.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination
Day 30 (FHA; N= 39,35,36,40)
|
114 µg/mL
Interval 93.0 to 140.0
|
147 µg/mL
Interval 119.0 to 182.0
|
183 µg/mL
Interval 148.0 to 226.0
|
241 µg/mL
Interval 198.0 to 294.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination
Day 1 (PRN)
|
20 µg/mL
Interval 14.0 to 28.0
|
16 µg/mL
Interval 11.0 to 23.0
|
17 µg/mL
Interval 12.0 to 25.0
|
21 µg/mL
Interval 14.0 to 31.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination
Day 30 (PRN; N= 39,35,36,40)
|
589 µg/mL
Interval 440.0 to 788.0
|
936 µg/mL
Interval 687.0 to 1273.0
|
1384 µg/mL
Interval 1020.0 to 1878.0
|
475 µg/mL
Interval 356.0 to 635.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (baseline) and Day 30 post vaccinationPopulation: Analysis was done on the per-protocol population.
The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP Booster Groups against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported.
Outcome measures
| Measure |
Group aP1
n=41 Participants
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP2
n=38 Participants
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP4
n=40 Participants
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group T5D2aP1
n=40 Participants
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP2
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP4
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP1
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP2
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP4
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Licensed TdaP
Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination
Day 30 (FHA; N= 41,38,38,40)
|
83 µg/mL
Interval 69.0 to 100.0
|
90 µg/mL
Interval 74.0 to 109.0
|
118 µg/mL
Interval 97.0 to 143.0
|
241 µg/mL
Interval 200.0 to 291.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination
Day 1 (PT)
|
4.35 µg/mL
Interval 2.86 to 6.6
|
4.97 µg/mL
Interval 3.22 to 7.67
|
4.8 µg/mL
Interval 3.15 to 7.32
|
5.07 µg/mL
Interval 3.32 to 7.73
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination
Day 30 (PT; N= 41,38,38,40)
|
62 µg/mL
Interval 49.0 to 80.0
|
72 µg/mL
Interval 56.0 to 93.0
|
160 µg/mL
Interval 124.0 to 206.0
|
86 µg/mL
Interval 68.0 to 110.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination
Day 1 (FHA)
|
20 µg/mL
Interval 14.0 to 28.0
|
16 µg/mL
Interval 12.0 to 23.0
|
23 µg/mL
Interval 17.0 to 33.0
|
20 µg/mL
Interval 15.0 to 28.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination
Day 1 (PRN)
|
13 µg/mL
Interval 8.72 to 21.0
|
21 µg/mL
Interval 13.0 to 32.0
|
27 µg/mL
Interval 17.0 to 41.0
|
21 µg/mL
Interval 14.0 to 32.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination
Day 30 (PRN; N= 41,38,38,40)
|
445 µg/mL
Interval 317.0 to 626.0
|
803 µg/mL
Interval 567.0 to 1138.0
|
1092 µg/mL
Interval 766.0 to 1555.0
|
496 µg/mL
Interval 353.0 to 696.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (baseline) and Day 30 post vaccinationPopulation: Analysis was done on the per-protocol population.
The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP booster groups, against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported.
Outcome measures
| Measure |
Group aP1
n=37 Participants
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP2
n=39 Participants
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP4
n=40 Participants
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group T5D2aP1
n=40 Participants
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP2
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP4
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP1
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP2
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP4
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Licensed TdaP
Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination
Day 30 (FHA)
|
116 µg/mL
Interval 96.0 to 140.0
|
100 µg/mL
Interval 83.0 to 121.0
|
113 µg/mL
Interval 94.0 to 135.0
|
252 µg/mL
Interval 210.0 to 303.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination
Day 1 (PT)
|
8.74 µg/mL
Interval 5.64 to 14.0
|
8.2 µg/mL
Interval 5.32 to 13.0
|
8.06 µg/mL
Interval 5.25 to 12.0
|
5.07 µg/mL
Interval 3.3 to 7.78
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination
Day 30 (PT)
|
83 µg/mL
Interval 64.0 to 108.0
|
93 µg/mL
Interval 72.0 to 120.0
|
157 µg/mL
Interval 122.0 to 202.0
|
93 µg/mL
Interval 72.0 to 119.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination
Day 1 (FHA)
|
24 µg/mL
Interval 17.0 to 33.0
|
27 µg/mL
Interval 20.0 to 38.0
|
26 µg/mL
Interval 18.0 to 36.0
|
20 µg/mL
Interval 15.0 to 28.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination
Day 1 (PRN)
|
30 µg/mL
Interval 20.0 to 47.0
|
22 µg/mL
Interval 14.0 to 34.0
|
28 µg/mL
Interval 19.0 to 43.0
|
21 µg/mL
Interval 14.0 to 32.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination
Day 30 (PRN)
|
837 µg/mL
Interval 624.0 to 1124.0
|
680 µg/mL
Interval 510.0 to 906.0
|
1024 µg/mL
Interval 772.0 to 1359.0
|
506 µg/mL
Interval 381.0 to 671.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 30 post vaccination/baseline (Day 1)Population: Analysis was done on the per-protocol population.
The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for different antigenic formulations of aP booster vaccines and for licensed comparator are reported.
Outcome measures
| Measure |
Group aP1
n=39 Participants
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP2
n=35 Participants
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP4
n=36 Participants
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group T5D2aP1
n=40 Participants
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP2
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP4
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP1
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP2
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP4
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Licensed TdaP
Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens
Day 30/Day 1 (PT)
|
18 Ratio
Interval 12.0 to 26.0
|
36 Ratio
Interval 24.0 to 54.0
|
49 Ratio
Interval 33.0 to 73.0
|
17 Ratio
Interval 12.0 to 25.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens
Day 30/Day 1 (FHA)
|
5.49 Ratio
Interval 3.99 to 7.54
|
9.42 Ratio
Interval 6.74 to 13.0
|
9.39 Ratio
Interval 6.75 to 13.0
|
12 Ratio
Interval 8.73 to 16.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens
Day 30/Day 1 (PRN)
|
30 Ratio
Interval 21.0 to 44.0
|
58 Ratio
Interval 39.0 to 86.0
|
81 Ratio
Interval 54.0 to 119.0
|
24 Ratio
Interval 16.0 to 34.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 30 post vaccination/baseline (Day 1)Population: Analysis was done on the per-protocol population.
The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported.
Outcome measures
| Measure |
Group aP1
n=41 Participants
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP2
n=38 Participants
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP4
n=38 Participants
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group T5D2aP1
n=40 Participants
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP2
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP4
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP1
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP2
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP4
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Licensed TdaP
Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens
Day 30/Day 1 (PT)
|
14 Ratio
Interval 9.58 to 21.0
|
15 Ratio
Interval 10.0 to 23.0
|
31 Ratio
Interval 21.0 to 46.0
|
17 Ratio
Interval 12.0 to 26.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens
Day 30/Day 1 (FHA)
|
4.24 Ratio
Interval 3.21 to 5.6
|
5.02 Ratio
Interval 3.76 to 6.71
|
5.11 Ratio
Interval 3.83 to 6.83
|
12 Ratio
Interval 9.01 to 16.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens
Day 30/Day 1 (PRN)
|
30 Ratio
Interval 21.0 to 45.0
|
38 Ratio
Interval 25.0 to 57.0
|
46 Ratio
Interval 31.0 to 69.0
|
24 Ratio
Interval 16.0 to 35.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 30 post vaccination/baseline (Day 1)Population: Analysis was done on the per-protocol population.
The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported.
Outcome measures
| Measure |
Group aP1
n=37 Participants
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP2
n=39 Participants
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP4
n=40 Participants
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group T5D2aP1
n=40 Participants
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP2
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP4
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP1
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP2
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP4
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Licensed TdaP
Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens
Day 30/Day 1 (PT)
|
9.51 Ratio
Interval 6.38 to 14.0
|
12 Ratio
Interval 7.9 to 17.0
|
20 Ratio
Interval 14.0 to 29.0
|
17 Ratio
Interval 12.0 to 25.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens
Day 30/Day 1 (FHA)
|
4.7 Ratio
Interval 3.47 to 6.38
|
3.95 Ratio
Interval 2.94 to 5.31
|
4.39 Ratio
Interval 3.28 to 5.89
|
12 Ratio
Interval 8.91 to 16.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens
Day 30/Day 1 (PRN)
|
27 Ratio
Interval 18.0 to 42.0
|
32 Ratio
Interval 21.0 to 48.0
|
36 Ratio
Interval 24.0 to 54.0
|
24 Ratio
Interval 16.0 to 36.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (baseline) and Day 30 post vaccinationPopulation: Analysis was done on the per-protocol population.
The percentages of subjects demonstrating diphtheria and tetanus antitoxin units \>= 0.1/mL following vaccination with different antigenic formulations of TdaP booster vaccine, is compared to the response to commercially available comparator.
Outcome measures
| Measure |
Group aP1
n=39 Participants
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP2
n=35 Participants
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP4
n=36 Participants
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group T5D2aP1
n=41 Participants
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP2
n=38 Participants
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP4
n=38 Participants
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP1
n=37 Participants
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP2
n=39 Participants
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP4
n=40 Participants
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Licensed TdaP
n=40 Participants
Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination
Day 1 (diphteria; N=42,38,39,41,38,40,37,39,40,40)
|
79 percentages of subjects
Interval 63.0 to 90.0
|
89 percentages of subjects
Interval 75.0 to 97.0
|
72 percentages of subjects
Interval 55.0 to 85.0
|
71 percentages of subjects
Interval 54.0 to 84.0
|
68 percentages of subjects
Interval 51.0 to 82.0
|
85 percentages of subjects
Interval 70.0 to 94.0
|
81 percentages of subjects
Interval 65.0 to 92.0
|
72 percentages of subjects
Interval 55.0 to 85.0
|
78 percentages of subjects
Interval 62.0 to 89.0
|
80 percentages of subjects
Interval 64.0 to 91.0
|
|
Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination
Day 30 (diphteria)
|
87 percentages of subjects
Interval 73.0 to 96.0
|
97 percentages of subjects
Interval 85.0 to 100.0
|
81 percentages of subjects
Interval 64.0 to 92.0
|
98 percentages of subjects
Interval 87.0 to 100.0
|
97 percentages of subjects
Interval 86.0 to 100.0
|
95 percentages of subjects
Interval 82.0 to 99.0
|
100 percentages of subjects
Interval 91.0 to 100.0
|
100 percentages of subjects
Interval 91.0 to 100.0
|
100 percentages of subjects
Interval 91.0 to 100.0
|
100 percentages of subjects
Interval 91.0 to 100.0
|
|
Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination
Day 1 (tetanus; N=42,38,39,41,38,40,37,39,40,40)
|
98 percentages of subjects
Interval 87.0 to 100.0
|
100 percentages of subjects
Interval 91.0 to 100.0
|
100 percentages of subjects
Interval 91.0 to 100.0
|
100 percentages of subjects
Interval 91.0 to 100.0
|
100 percentages of subjects
Interval 91.0 to 100.0
|
95 percentages of subjects
Interval 83.0 to 99.0
|
100 percentages of subjects
Interval 91.0 to 100.0
|
100 percentages of subjects
Interval 91.0 to 100.0
|
98 percentages of subjects
Interval 87.0 to 100.0
|
95 percentages of subjects
Interval 83.0 to 99.0
|
|
Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination
Day 30 (tetanus)
|
100 percentages of subjects
Interval 91.0 to 100.0
|
100 percentages of subjects
Interval 90.0 to 100.0
|
100 percentages of subjects
Interval 90.0 to 100.0
|
100 percentages of subjects
Interval 91.0 to 100.0
|
100 percentages of subjects
Interval 91.0 to 100.0
|
97 percentages of subjects
Interval 86.0 to 100.0
|
100 percentages of subjects
Interval 91.0 to 100.0
|
100 percentages of subjects
Interval 91.0 to 100.0
|
100 percentages of subjects
Interval 91.0 to 100.0
|
100 percentages of subjects
Interval 91.0 to 100.0
|
SECONDARY outcome
Timeframe: Day 30 post vaccinationPopulation: Analysis was done on the per-protocol population.
Comparison of antibody responses against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of aP and TdaP booster vaccines and licensed comparator, are reported in terms of the percentages of subjects demonstrating 2- and 4-fold increase in GMCs from baseline.
Outcome measures
| Measure |
Group aP1
n=39 Participants
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP2
n=35 Participants
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP4
n=36 Participants
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group T5D2aP1
n=41 Participants
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP2
n=38 Participants
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP4
n=38 Participants
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP1
n=37 Participants
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP2
n=39 Participants
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP4
n=40 Participants
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Licensed TdaP
n=40 Participants
Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination.
2-Fold (PT)
|
100 percentage of subjects
Interval 91.0 to 100.0
|
100 percentage of subjects
Interval 90.0 to 100.0
|
94 percentage of subjects
Interval 81.0 to 99.0
|
95 percentage of subjects
Interval 83.0 to 99.0
|
95 percentage of subjects
Interval 82.0 to 99.0
|
100 percentage of subjects
Interval 91.0 to 100.0
|
89 percentage of subjects
Interval 75.0 to 97.0
|
90 percentage of subjects
Interval 76.0 to 97.0
|
95 percentage of subjects
Interval 83.0 to 99.0
|
100 percentage of subjects
Interval 91.0 to 100.0
|
|
Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination.
4-Fold (PT)
|
92 percentage of subjects
Interval 79.0 to 98.0
|
100 percentage of subjects
Interval 90.0 to 100.0
|
92 percentage of subjects
Interval 78.0 to 98.0
|
80 percentage of subjects
Interval 65.0 to 91.0
|
76 percentage of subjects
Interval 60.0 to 89.0
|
100 percentage of subjects
Interval 91.0 to 100.0
|
81 percentage of subjects
Interval 65.0 to 92.0
|
77 percentage of subjects
Interval 61.0 to 89.0
|
93 percentage of subjects
Interval 80.0 to 98.0
|
98 percentage of subjects
Interval 87.0 to 100.0
|
|
Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination.
2-Fold (FHA)
|
85 percentage of subjects
Interval 69.0 to 94.0
|
94 percentage of subjects
Interval 81.0 to 99.0
|
89 percentage of subjects
Interval 74.0 to 97.0
|
80 percentage of subjects
Interval 65.0 to 91.0
|
95 percentage of subjects
Interval 82.0 to 99.0
|
95 percentage of subjects
Interval 82.0 to 99.0
|
76 percentage of subjects
Interval 59.0 to 88.0
|
77 percentage of subjects
Interval 61.0 to 89.0
|
90 percentage of subjects
Interval 76.0 to 97.0
|
95 percentage of subjects
Interval 83.0 to 99.0
|
|
Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination.
4-Fold (FHA)
|
59 percentage of subjects
Interval 42.0 to 74.0
|
83 percentage of subjects
Interval 66.0 to 93.0
|
83 percentage of subjects
Interval 67.0 to 94.0
|
46 percentage of subjects
Interval 31.0 to 63.0
|
61 percentage of subjects
Interval 43.0 to 76.0
|
58 percentage of subjects
Interval 41.0 to 74.0
|
46 percentage of subjects
Interval 29.0 to 63.0
|
56 percentage of subjects
Interval 40.0 to 72.0
|
53 percentage of subjects
Interval 36.0 to 68.0
|
83 percentage of subjects
Interval 67.0 to 93.0
|
|
Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination.
2-Fold (PRN)
|
100 percentage of subjects
Interval 91.0 to 100.0
|
100 percentage of subjects
Interval 90.0 to 100.0
|
100 percentage of subjects
Interval 90.0 to 100.0
|
98 percentage of subjects
Interval 87.0 to 100.0
|
100 percentage of subjects
Interval 91.0 to 100.0
|
100 percentage of subjects
Interval 91.0 to 100.0
|
97 percentage of subjects
Interval 86.0 to 100.0
|
92 percentage of subjects
Interval 79.0 to 98.0
|
100 percentage of subjects
Interval 91.0 to 100.0
|
100 percentage of subjects
Interval 91.0 to 100.0
|
|
Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination.
4-Fold (PRN)
|
92 percentage of subjects
Interval 79.0 to 98.0
|
100 percentage of subjects
Interval 90.0 to 100.0
|
100 percentage of subjects
Interval 90.0 to 100.0
|
90 percentage of subjects
Interval 77.0 to 97.0
|
95 percentage of subjects
Interval 82.0 to 99.0
|
97 percentage of subjects
Interval 86.0 to 100.0
|
89 percentage of subjects
Interval 75.0 to 97.0
|
85 percentage of subjects
Interval 69.0 to 94.0
|
98 percentage of subjects
Interval 87.0 to 100.0
|
90 percentage of subjects
Interval 76.0 to 97.0
|
SECONDARY outcome
Timeframe: Day 1 (baseline) and Day 30 post vaccinationPopulation: Analysis was done on the per-protocol population.
The GMCs of antibodies against diphtheria and tetanus antigens following vaccination with different formulations of TdaP booster are compared with the response to the commercially available comparator.
Outcome measures
| Measure |
Group aP1
n=39 Participants
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP2
n=35 Participants
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP4
n=36 Participants
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group T5D2aP1
n=41 Participants
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP2
n=38 Participants
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP4
n=38 Participants
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP1
n=37 Participants
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP2
n=39 Participants
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP4
n=40 Participants
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Licensed TdaP
n=40 Participants
Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination
Day 30 (tetanus)
|
2.19 IU/mL
Interval 1.91 to 2.52
|
2.18 IU/mL
Interval 1.88 to 2.52
|
2.19 IU/mL
Interval 1.89 to 2.53
|
8.15 IU/mL
Interval 6.73 to 9.88
|
8.82 IU/mL
Interval 7.23 to 11.0
|
7.01 IU/mL
Interval 5.74 to 8.56
|
8.23 IU/mL
Interval 6.73 to 10.0
|
6.82 IU/mL
Interval 5.6 to 8.32
|
7.44 IU/mL
Interval 6.13 to 9.04
|
8.49 IU/mL
Interval 6.99 to 10.0
|
|
GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination
Day 1 (tetanus; N=42,38,39,41,38,40,37,39,40,40)
|
2.45 IU/mL
Interval 1.9 to 3.16
|
2.11 IU/mL
Interval 1.61 to 2.76
|
2.27 IU/mL
Interval 1.74 to 2.96
|
1.93 IU/mL
Interval 1.44 to 2.58
|
1.99 IU/mL
Interval 1.47 to 2.68
|
2.07 IU/mL
Interval 1.54 to 2.77
|
2.04 IU/mL
Interval 1.5 to 2.76
|
2.62 IU/mL
Interval 1.95 to 3.53
|
1.92 IU/mL
Interval 1.43 to 2.58
|
1.89 IU/mL
Interval 1.41 to 2.53
|
|
GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination
Day 1 (diphteria; N=42,38,39,41,38,40,37,39,40,40)
|
0.4 IU/mL
Interval 0.27 to 0.6
|
0.43 IU/mL
Interval 0.28 to 0.65
|
0.25 IU/mL
Interval 0.17 to 0.38
|
0.31 IU/mL
Interval 0.2 to 0.46
|
0.15 IU/mL
Interval 0.098 to 0.23
|
0.29 IU/mL
Interval 0.19 to 0.44
|
0.31 IU/mL
Interval 0.2 to 0.48
|
0.25 IU/mL
Interval 0.16 to 0.39
|
0.25 IU/mL
Interval 0.17 to 0.39
|
0.3 IU/mL
Interval 0.19 to 0.45
|
|
GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination
Day 30 (diphteria)
|
0.39 IU/mL
Interval 0.32 to 0.49
|
0.39 IU/mL
Interval 0.31 to 0.5
|
0.37 IU/mL
Interval 0.29 to 0.46
|
1.48 IU/mL
Interval 1.1 to 1.99
|
1.41 IU/mL
Interval 1.04 to 1.92
|
1.63 IU/mL
Interval 1.2 to 2.21
|
2.7 IU/mL
Interval 1.97 to 3.69
|
2.19 IU/mL
Interval 1.62 to 2.97
|
2.47 IU/mL
Interval 1.83 to 3.33
|
1.79 IU/mL
Interval 1.32 to 2.41
|
SECONDARY outcome
Timeframe: Day 30 post vaccination/Day 1Population: Analysis was done on the per-protocol population.
The GMRs of post vaccination versus pre vaccination GMCs of antibodies against diphtheria and tetanus antigens for different formulations of TdaP booster and commercially available comparator versus GMCs at baseline are reported.
Outcome measures
| Measure |
Group aP1
n=39 Participants
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP2
n=35 Participants
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP4
n=36 Participants
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group T5D2aP1
n=41 Participants
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP2
n=38 Participants
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP4
n=38 Participants
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP1
n=37 Participants
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP2
n=39 Participants
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP4
n=40 Participants
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Licensed TdaP
n=40 Participants
Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens
Day 30/day 1 (diphtheria)
|
1.05 Ratio
Interval 0.94 to 1.16
|
1.05 Ratio
Interval 0.93 to 1.17
|
1.19 Ratio
Interval 1.07 to 1.33
|
5.24 Ratio
Interval 3.66 to 7.49
|
8.58 Ratio
Interval 5.91 to 12.0
|
5.62 Ratio
Interval 3.87 to 8.16
|
9.18 Ratio
Interval 6.3 to 13.0
|
8.39 Ratio
Interval 5.81 to 12.0
|
9.54 Ratio
Interval 6.64 to 14.0
|
6.1 Ratio
Interval 4.25 to 8.78
|
|
GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens
Day 30/day 1 (tetanus)
|
0.94 Ratio
Interval 0.88 to 1.02
|
0.92 Ratio
Interval 0.86 to 1.0
|
0.97 Ratio
Interval 0.9 to 1.04
|
4.2 Ratio
Interval 3.01 to 5.86
|
4.43 Ratio
Interval 3.14 to 6.26
|
3.43 Ratio
Interval 2.43 to 4.84
|
4.02 Ratio
Interval 2.83 to 5.71
|
2.64 Ratio
Interval 1.88 to 3.71
|
3.86 Ratio
Interval 2.76 to 5.41
|
4.5 Ratio
Interval 3.21 to 6.3
|
Adverse Events
Group aP1
Serious events: 4 serious events
Other events: 36 other events
Deaths: 0 deaths
Group aP2
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
Group aP4
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Group T5D2aP1
Serious events: 1 serious events
Other events: 38 other events
Deaths: 0 deaths
Group T5D2aP2
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Group T5D2aP4
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Group T5D4aP1
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Group T5D4aP2
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
Group T5D4aP4
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
Licensed TdaP
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group aP1
n=42 participants at risk
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP2
n=42 participants at risk
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP4
n=41 participants at risk
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group T5D2aP1
n=42 participants at risk
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP2
n=42 participants at risk
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP4
n=42 participants at risk
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP1
n=41 participants at risk
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP2
n=42 participants at risk
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP4
n=42 participants at risk
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Licensed TdaP
n=42 participants at risk
Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Peritonsillar abscess
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
Infections and infestations
Tonsillitis streptococcal
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
Psychiatric disorders
Depression
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
Psychiatric disorders
Dysthymic disorder
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
Other adverse events
| Measure |
Group aP1
n=42 participants at risk
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP2
n=42 participants at risk
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group aP4
n=41 participants at risk
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
|
Group T5D2aP1
n=42 participants at risk
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP2
n=42 participants at risk
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D2aP4
n=42 participants at risk
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP1
n=41 participants at risk
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP2
n=42 participants at risk
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Group T5D4aP4
n=42 participants at risk
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
|
Licensed TdaP
n=42 participants at risk
Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Axillary pain
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
7.1%
3/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
7.1%
3/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
4.8%
2/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
4.9%
2/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
3/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
14.3%
6/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
4.9%
2/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
4.8%
2/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
4.8%
2/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
11.9%
5/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
9.8%
4/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
14.3%
6/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
16.7%
7/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
General disorders
Fatigue
|
45.2%
19/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
33.3%
14/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
31.7%
13/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
31.0%
13/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
35.7%
15/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
42.9%
18/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
51.2%
21/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
35.7%
15/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
38.1%
16/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
28.6%
12/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
General disorders
Injection site erythema
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
4.8%
2/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
16.7%
7/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
4.9%
2/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
9.5%
4/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
7.1%
3/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
General disorders
Injection site induration
|
4.8%
2/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
9.5%
4/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
7.1%
3/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
14.3%
6/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
19.5%
8/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
9.5%
4/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
7.1%
3/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
11.9%
5/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
General disorders
Injection site movement impairment
|
4.8%
2/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
7.1%
3/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
4.9%
2/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
4.8%
2/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
4.8%
2/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
7.3%
3/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
4.8%
2/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
General disorders
Injection site pain
|
71.4%
30/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
76.2%
32/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
75.6%
31/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
83.3%
35/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
90.5%
38/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
85.7%
36/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
97.6%
40/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
83.3%
35/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
92.9%
39/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
73.8%
31/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
General disorders
Injection site pruritus
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
9.5%
4/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
7.1%
3/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
4.8%
2/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
11.9%
5/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
7.3%
3/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
7.1%
3/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
14.3%
6/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
11.9%
5/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
General disorders
Pyrexia
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
4.9%
2/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
4.8%
2/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
7.3%
3/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
4.8%
2/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
4.8%
2/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.9%
5/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
11.9%
5/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
4.9%
2/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
9.5%
4/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
7.1%
3/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
7.3%
3/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
4.8%
2/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
2/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
7.3%
3/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
9.5%
4/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
7.1%
3/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
12.2%
5/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
9.5%
4/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
19.0%
8/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
4.8%
2/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.8%
10/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
21.4%
9/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
9.8%
4/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
19.0%
8/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
23.8%
10/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
28.6%
12/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
34.1%
14/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
19.0%
8/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
21.4%
9/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
26.2%
11/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
Nervous system disorders
Headache
|
45.2%
19/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
35.7%
15/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
31.7%
13/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
21.4%
9/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
33.3%
14/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
31.0%
13/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
39.0%
16/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
35.7%
15/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
45.2%
19/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
31.0%
13/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
9.5%
4/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
4.9%
2/41 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
7.1%
3/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
2.4%
1/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
0.00%
0/42 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60