Trial Outcomes & Findings for Persistency Study After aP / Tdap Booster Vaccines in Adult Subjects (V113_01 Extension 1) (NCT NCT02382913)
NCT ID: NCT02382913
Last Updated: 2016-03-24
Results Overview
The antibody response against the pertussis antigen components (PT, FHA and PRN) at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in aP1, aP2, aP4 Groups versus the response to the commercially available Tdap comparator. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
315 participants
Primary outcome timeframe
Day 1
Results posted on
2016-03-24
Participant Flow
Subjects were enrolled at one site in Belgium. \- V113\_01 parent study number: NCT01529645
All enrolled subjects were included in the trial.
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 parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Group aP2
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Group aP4
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 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 parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 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 parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 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 parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 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 parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 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 parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 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 parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 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 parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
36
|
32
|
27
|
33
|
30
|
37
|
30
|
30
|
33
|
|
Overall Study
COMPLETED
|
27
|
36
|
32
|
27
|
33
|
30
|
37
|
30
|
30
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Persistency Study After aP / Tdap Booster Vaccines in Adult Subjects (V113_01 Extension 1)
Baseline characteristics by cohort
| Measure |
Group aP1
n=27 Participants
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Group aP2
n=36 Participants
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Group aP4
n=32 Participants
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Group T5D2aP1
n=27 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 a fixed dose of tetanus toxoid) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Group T5D2aP2
n=33 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 parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Group T5D2aP4
n=30 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 parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 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 parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Group T5D4aP2
n=30 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 parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Group T5D4aP4
n=30 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 parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Licensed Tdap
n=33 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 parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Total
n=315 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
30.2 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
29.5 years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
30.3 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
31.3 years
STANDARD_DEVIATION 6.3 • n=4 Participants
|
30.9 years
STANDARD_DEVIATION 5.7 • n=21 Participants
|
30 years
STANDARD_DEVIATION 5.6 • n=8 Participants
|
28.2 years
STANDARD_DEVIATION 4.4 • n=8 Participants
|
30.1 years
STANDARD_DEVIATION 4.6 • n=24 Participants
|
31.3 years
STANDARD_DEVIATION 5.9 • n=42 Participants
|
31.5 years
STANDARD_DEVIATION 6.7 • n=42 Participants
|
30.3 years
STANDARD_DEVIATION 5.6 • n=42 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
21 Participants
n=42 Participants
|
187 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
17 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
128 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Analysis were done on per protocol set (PPS) i.e., All subjects in the all enrolled set who provided immunogenicity data at V113\_01E1 visit 1 and: * correctly received the vaccine in the V113\_01 parent study * had no major protocol deviations leading to exclusion or were not excluded due to other reasons as defined prior to analysis
The antibody response against the pertussis antigen components (PT, FHA and PRN) at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in aP1, aP2, aP4 Groups versus the response to the commercially available Tdap comparator. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups.
Outcome measures
| Measure |
Group aP1
n=27 Participants
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Group aP2
n=34 Participants
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Group aP4
n=32 Participants
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Licensed Tdap
n=32 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 parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
|---|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1.
PT
|
28 IU/mL
Interval 18.0 to 44.0
|
31 IU/mL
Interval 21.0 to 46.0
|
48 IU/mL
Interval 32.0 to 72.0
|
18 IU/mL
Interval 12.0 to 27.0
|
|
Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1.
FHA
|
43 IU/mL
Interval 31.0 to 59.0
|
54 IU/mL
Interval 41.0 to 71.0
|
60 IU/mL
Interval 45.0 to 80.0
|
63 IU/mL
Interval 47.0 to 84.0
|
|
Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1.
PRN
|
206 IU/mL
Interval 138.0 to 308.0
|
276 IU/mL
Interval 193.0 to 394.0
|
396 IU/mL
Interval 274.0 to 572.0
|
126 IU/mL
Interval 87.0 to 182.0
|
PRIMARY outcome
Timeframe: Day 1Population: Analysis were done on per protocol set.
The antibody response against the pertussis antigen components (PT, FHA and PRN) in serum at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in T5D2aP1, T5D2aP2 and T5D2aP4 Groups versus the response to the commercially available Tdap comparator. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups.
Outcome measures
| Measure |
Group aP1
n=26 Participants
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Group aP2
n=31 Participants
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Group aP4
n=28 Participants
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Licensed Tdap
n=32 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 parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
|---|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1.
PT
|
17 IU/mL
Interval 12.0 to 24.0
|
22 IU/mL
Interval 15.0 to 31.0
|
34 IU/mL
Interval 24.0 to 48.0
|
18 IU/mL
Interval 13.0 to 25.0
|
|
Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1.
FHA
|
41 IU/mL
Interval 29.0 to 56.0
|
32 IU/mL
Interval 24.0 to 44.0
|
51 IU/mL
Interval 37.0 to 69.0
|
63 IU/mL
Interval 47.0 to 84.0
|
|
Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1.
PRN
|
93 IU/mL
Interval 59.0 to 146.0
|
248 IU/mL
Interval 165.0 to 375.0
|
373 IU/mL
Interval 242.0 to 575.0
|
126 IU/mL
Interval 84.0 to 189.0
|
PRIMARY outcome
Timeframe: Day 1Population: Analysis were done on per protocol set.
The antibody response against the pertussis antigen components (PT, FHA and PRN) in serum at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in T5D4aP1, T5D4aP2 and T5D4aP4 Groups versus the response to the commercially available Tdap comparator. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups.
Outcome measures
| Measure |
Group aP1
n=33 Participants
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Group aP2
n=28 Participants
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Group aP4
n=29 Participants
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Licensed Tdap
n=32 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 parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
|---|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1.
PT
|
31 IU/mL
Interval 22.0 to 43.0
|
31 IU/mL
Interval 21.0 to 44.0
|
43 IU/mL
Interval 30.0 to 61.0
|
18 IU/mL
Interval 13.0 to 25.0
|
|
Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1.
FHA
|
51 IU/mL
Interval 38.0 to 67.0
|
48 IU/mL
Interval 35.0 to 65.0
|
58 IU/mL
Interval 43.0 to 78.0
|
63 IU/mL
Interval 47.0 to 84.0
|
|
Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1.
PRN
|
247 IU/mL
Interval 166.0 to 368.0
|
266 IU/mL
Interval 172.0 to 410.0
|
292 IU/mL
Interval 191.0 to 448.0
|
126 IU/mL
Interval 84.0 to 189.0
|
PRIMARY outcome
Timeframe: Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1Population: Analysis were done on per protocol set. Note: Number of participants analyzed for Day 1 of V113\_01E1/ Day 180 of V113\_01 PT, FHA and PRN was 27, 32, 31, 32 respectively.
Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113\_01 time points to V113\_01E1 day 1. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups.
Outcome measures
| Measure |
Group aP1
n=27 Participants
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Group aP2
n=34 Participants
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Group aP4
n=32 Participants
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Licensed Tdap
n=32 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 parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
|---|---|---|---|---|
|
Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 365 of V113_01 (PRN)
|
0.62 Ratios
Interval 0.55 to 0.7
|
0.63 Ratios
Interval 0.56 to 0.7
|
0.59 Ratios
Interval 0.53 to 0.66
|
0.72 Ratios
Interval 0.64 to 0.8
|
|
Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 1 of V113_01 (PT)
|
7.21 Ratios
Interval 4.77 to 11.0
|
7.63 Ratios
Interval 5.29 to 11.0
|
11 Ratios
Interval 7.48 to 16.0
|
4.28 Ratios
Interval 2.93 to 6.25
|
|
Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 8 of V113_01 (PT)
|
2.93 Ratios
Interval 1.83 to 4.69
|
1.50 Ratios
Interval 0.99 to 2.28
|
1.60 Ratios
Interval 1.04 to 2.46
|
1.00 Ratios
Interval 0.65 to 1.54
|
|
Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 30 of V113_01 (PT)
|
0.30 Ratios
Interval 0.24 to 0.38
|
0.24 Ratios
Interval 0.2 to 0.3
|
0.26 Ratios
Interval 0.21 to 0.32
|
0.21 Ratios
Interval 0.17 to 0.26
|
|
Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 180 of V113_01 (PT)
|
0.48 Ratios
Interval 0.41 to 0.56
|
0.45 Ratios
Interval 0.39 to 0.52
|
0.42 Ratios
Interval 0.36 to 0.48
|
0.42 Ratios
Interval 0.36 to 0.49
|
|
Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 365 of V113_01 (PT)
|
0.68 Ratios
Interval 0.59 to 0.79
|
0.63 Ratios
Interval 0.55 to 0.72
|
0.56 Ratios
Interval 0.49 to 0.64
|
0.67 Ratios
Interval 0.59 to 0.77
|
|
Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 1 of V113_01 (FHA)
|
2.25 Ratios
Interval 1.67 to 3.05
|
3.25 Ratios
Interval 2.49 to 4.25
|
2.75 Ratios
Interval 2.09 to 3.63
|
3.36 Ratios
Interval 2.55 to 4.44
|
|
Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 8 of V113_01 (FHA)
|
1.06 Ratios
Interval 0.77 to 1.46
|
1.00 Ratios
Interval 0.75 to 1.32
|
0.93 Ratios
Interval 0.69 to 1.24
|
0.62 Ratios
Interval 0.46 to 0.83
|
|
Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 30 of V113_01 (FHA)
|
0.39 Ratios
Interval 0.3 to 0.5
|
0.34 Ratios
Interval 0.27 to 0.43
|
0.32 Ratios
Interval 0.25 to 0.4
|
0.26 Ratios
Interval 0.21 to 0.33
|
|
Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 180 of V113_01 (FHA)
|
0.64 Ratios
Interval 0.54 to 0.77
|
0.69 Ratios
Interval 0.58 to 0.81
|
0.65 Ratios
Interval 0.55 to 0.77
|
0.54 Ratios
Interval 0.45 to 0.63
|
|
Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 365 of V113_01 (FHA)
|
0.83 Ratios
Interval 0.7 to 0.98
|
0.95 Ratios
Interval 0.82 to 1.1
|
0.78 Ratios
Interval 0.67 to 0.91
|
0.79 Ratios
Interval 0.68 to 0.92
|
|
Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 1 of V113_01 (PRN)
|
11 Ratios
Interval 6.75 to 17.0
|
15 Ratios
Interval 10.0 to 23.0
|
20 Ratios
Interval 13.0 to 31.0
|
6.61 Ratios
Interval 4.36 to 10.0
|
|
Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 8 of V113_01 (PRN)
|
1.66 Ratios
Interval 1.12 to 2.45
|
1.31 Ratios
Interval 0.92 to 1.85
|
0.85 Ratios
Interval 0.59 to 1.22
|
0.88 Ratios
Interval 0.61 to 1.26
|
|
Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 30 of V113_01 (PRN)
|
0.33 Ratios
Interval 0.26 to 0.41
|
0.30 Ratios
Interval 0.24 to 0.36
|
0.27 Ratios
Interval 0.22 to 0.33
|
0.29 Ratios
Interval 0.24 to 0.36
|
|
Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 180 of V113_01 (PRN)
|
0.45 Ratios
Interval 0.39 to 0.51
|
0.47 Ratios
Interval 0.42 to 0.54
|
0.47 Ratios
Interval 0.42 to 0.54
|
0.48 Ratios
Interval 0.42 to 0.54
|
PRIMARY outcome
Timeframe: Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1Population: Analysis were done on per protocol set
Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113\_01 time points to V113\_01E1 day 1. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups.
Outcome measures
| Measure |
Group aP1
n=26 Participants
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Group aP2
n=31 Participants
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Group aP4
n=28 Participants
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Licensed Tdap
n=32 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 parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
|---|---|---|---|---|
|
Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 1 of V113_01 (PT)
|
3.70 Ratios
Interval 2.4 to 5.71
|
3.58 Ratios
Interval 2.41 to 5.32
|
6.67 Ratios
Interval 4.39 to 10.0
|
4.28 Ratios
Interval 2.9 to 6.33
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 8 of V113_01 (PT)
|
1.05 Ratios
Interval 0.71 to 1.55
|
1.03 Ratios
Interval 0.72 to 1.46
|
0.80 Ratios
Interval 0.55 to 1.16
|
1.00 Ratios
Interval 0.71 to 1.42
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 30 of V113_01 (PT)
|
0.30 Ratios
Interval 0.24 to 0.37
|
0.30 Ratios
Interval 0.25 to 0.36
|
0.26 Ratios
Interval 0.21 to 0.32
|
0.21 Ratios
Interval 0.17 to 0.25
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 180 of V113_01 (PT)
|
0.44 Ratios
Interval 0.37 to 0.52
|
0.47 Ratios
Interval 0.4 to 0.56
|
0.41 Ratios
Interval 0.35 to 0.49
|
0.42 Ratios
Interval 0.36 to 0.49
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 365 of V113_01 (PT)
|
0.70 Ratios
Interval 0.61 to 0.81
|
0.63 Ratios
Interval 0.56 to 0.72
|
0.61 Ratios
Interval 0.53 to 0.7
|
0.67 Ratios
Interval 0.59 to 0.77
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 1 of V113_01 (FHA)
|
1.99 Ratios
Interval 1.46 to 2.71
|
1.79 Ratios
Interval 1.35 to 2.39
|
2.04 Ratios
Interval 1.51 to 2.75
|
3.36 Ratios
Interval 2.54 to 4.45
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 8 of V113_01 (FHA)
|
0.94 Ratios
Interval 0.71 to 1.24
|
0.78 Ratios
Interval 0.6 to 1.0
|
0.84 Ratios
Interval 0.64 to 1.09
|
0.62 Ratios
Interval 0.48 to 0.79
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 30 of V113_01 (FHA)
|
0.49 Ratios
Interval 0.37 to 0.64
|
0.39 Ratios
Interval 0.31 to 0.51
|
0.40 Ratios
Interval 0.31 to 0.52
|
0.26 Ratios
Interval 0.21 to 0.34
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 180 of V113_01 (FHA)
|
0.76 Ratios
Interval 0.62 to 0.94
|
0.63 Ratios
Interval 0.52 to 0.77
|
0.66 Ratios
Interval 0.54 to 0.81
|
0.54 Ratios
Interval 0.44 to 0.65
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 365 of V113_01 (FHA)
|
0.94 Ratios
Interval 0.77 to 1.13
|
0.84 Ratios
Interval 0.7 to 1.0
|
0.87 Ratios
Interval 0.72 to 1.05
|
0.79 Ratios
Interval 0.67 to 0.94
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 1 of V113_01 (PRN)
|
7.65 Ratios
Interval 4.71 to 12.0
|
10 Ratios
Interval 6.71 to 16.0
|
11 Ratios
Interval 6.91 to 18.0
|
6.61 Ratios
Interval 4.27 to 10.0
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 8 of V113_01 (PRN)
|
1.41 Ratios
Interval 0.96 to 2.06
|
1.11 Ratios
Interval 0.78 to 1.57
|
0.91 Ratios
Interval 0.63 to 1.32
|
0.88 Ratios
Interval 0.62 to 1.24
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 30 of V113_01 (PRN)
|
0.35 Ratios
Interval 0.28 to 0.43
|
0.32 Ratios
Interval 0.26 to 0.39
|
0.30 Ratios
Interval 0.24 to 0.37
|
0.29 Ratios
Interval 0.24 to 0.36
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 180 of V113_01 (PRN)
|
0.43 Ratios
Interval 0.36 to 0.5
|
0.47 Ratios
Interval 0.41 to 0.55
|
0.50 Ratios
Interval 0.43 to 0.59
|
0.48 Ratios
Interval 0.41 to 0.55
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 365 of V113_01 (PRN)
|
0.70 Ratios
Interval 0.62 to 0.79
|
0.60 Ratios
Interval 0.54 to 0.73
|
0.59 Ratios
Interval 0.52 to 0.67
|
0.72 Ratios
Interval 0.64 to 0.8
|
PRIMARY outcome
Timeframe: Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1Population: Analysis were done on per protocol set. Note: Number of participants analyzed for Day 1 of V113\_01E1/ Day 180 of V113\_01 FHA and PRN was 33, 28, 28, 32 respectively.
Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113\_01 time points to V113\_01E1 day 1. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups.
Outcome measures
| Measure |
Group aP1
n=33 Participants
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Group aP2
n=28 Participants
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Group aP4
n=29 Participants
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
Licensed Tdap
n=32 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 parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study.
|
|---|---|---|---|---|
|
Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 1 of V113_01 (PT)
|
3.40 Ratios
Interval 2.32 to 5.0
|
3.82 Ratios
Interval 2.51 to 5.79
|
5.90 Ratios
Interval 3.92 to 8.9
|
4.28 Ratios
Interval 2.9 to 6.33
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 8 of V113_01 (PT)
|
1.02 Ratios
Interval 0.73 to 1.44
|
0.98 Ratios
Interval 0.67 to 1.42
|
1.11 Ratios
Interval 0.77 to 1.6
|
1.00 Ratios
Interval 0.71 to 1.42
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 30 of V113_01 (PT)
|
0.37 Ratios
Interval 0.3 to 0.45
|
0.32 Ratios
Interval 0.26 to 0.39
|
0.32 Ratios
Interval 0.26 to 0.39
|
0.21 Ratios
Interval 0.17 to 0.25
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 180 of V113_01 (PT)
|
0.60 Ratios
Interval 0.52 to 0.71
|
0.44 Ratios
Interval 0.37 to 0.53
|
0.48 Ratios
Interval 0.4 to 0.57
|
0.42 Ratios
Interval 0.36 to 0.49
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 365 of V113_01 (PT)
|
0.81 Ratios
Interval 0.71 to 0.92
|
0.64 Ratios
Interval 0.56 to 0.73
|
0.65 Ratios
Interval 0.57 to 0.74
|
0.67 Ratios
Interval 0.59 to 0.77
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 1 of V113_01 (FHA)
|
2.09 Ratios
Interval 1.58 to 2.75
|
1.67 Ratios
Interval 1.23 to 2.25
|
2.19 Ratios
Interval 1.63 to 2.94
|
3.36 Ratios
Interval 2.54 to 4.45
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 8 of V113_01 (FHA)
|
0.85 Ratios
Interval 0.67 to 1.09
|
0.82 Ratios
Interval 0.63 to 1.08
|
0.99 Ratios
Interval 0.76 to 1.28
|
0.62 Ratios
Interval 0.48 to 0.79
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 30 of V113_01 (FHA)
|
0.45 Ratios
Interval 0.36 to 0.58
|
0.49 Ratios
Interval 0.38 to 0.64
|
0.50 Ratios
Interval 0.39 to 0.65
|
0.26 Ratios
Interval 0.21 to 0.34
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 180 of V113_01 (FHA)
|
0.78 Ratios
Interval 0.65 to 0.95
|
0.72 Ratios
Interval 0.58 to 0.88
|
0.79 Ratios
Interval 0.64 to 0.97
|
0.54 Ratios
Interval 0.44 to 0.65
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 365 of V113_01 (FHA)
|
0.99 Ratios
Interval 0.84 to 1.18
|
0.83 Ratios
Interval 0.69 to 1.0
|
0.97 Ratios
Interval 0.81 to 1.17
|
0.79 Ratios
Interval 0.67 to 0.94
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 1 of V113_01 (PRN)
|
8.76 Ratios
Interval 5.7 to 13.0
|
12 Ratios
Interval 7.5 to 19.0
|
13 Ratios
Interval 8.23 to 21.0
|
6.61 Ratios
Interval 4.27 to 10.0
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 8 of V113_01 (PRN)
|
1.24 Ratios
Interval 0.88 to 1.73
|
1.41 Ratios
Interval 0.98 to 2.03
|
1.11 Ratios
Interval 0.77 to 1.59
|
0.88 Ratios
Interval 0.62 to 1.24
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 30 of V113_01 (PRN)
|
0.33 Ratios
Interval 0.27 to 0.4
|
0.37 Ratios
Interval 0.3 to 0.46
|
0.33 Ratios
Interval 0.27 to 0.4
|
0.29 Ratios
Interval 0.24 to 0.36
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 180 of V113_01 (PRN)
|
0.57 Ratios
Interval 0.49 to 0.66
|
0.49 Ratios
Interval 0.41 to 0.57
|
0.48 Ratios
Interval 0.41 to 0.56
|
0.48 Ratios
Interval 0.41 to 0.55
|
|
Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Day 1 of V113_01E1/ Day 365 of V113_01 (PRN)
|
0.67 Ratios
Interval 0.6 to 0.75
|
0.64 Ratios
Interval 0.57 to 0.73
|
0.58 Ratios
Interval 0.52 to 0.66
|
0.72 Ratios
Interval 0.64 to 0.8
|
Adverse Events
Group aP1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group aP2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group aP4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group T5D2aP1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group T5D2aP2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group T5D2aP4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group T5D4aP1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group T5D4aP2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group T5D4aP4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Licensed Tdap
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER