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Persistency Study After aP / Tdap Booster Vaccines in Adult Subjects (V113_01 Extension 1)

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ClinicalTrials.gov Identifier: NCT02382913
Recruitment Status : Completed
First Posted : March 9, 2015
Results First Posted : February 12, 2016
Last Update Posted : March 24, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Pertussis
Interventions Biological: aP booster
Biological: TdaP booster
Biological: Licensed TdaP booster (Boostrix®)
Enrollment 315
Recruitment Details

Subjects were enrolled at one site in Belgium.

- V113_01 parent study number: NCT01529645

Pre-assignment Details All enrolled subjects were included in the trial.
Arm/Group Title Group aP1 Group aP2 Group aP4 Group T5D2aP1 Group T5D2aP2 Group T5D2aP4 Group T5D4aP1 Group T5D4aP2 Group T5D4aP4 Licensed Tdap
Hide Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
Period Title: Overall Study
Started 27 36 32 27 33 30 37 30 30 33
Completed 27 36 32 27 33 30 37 30 30 33
Not Completed 0 0 0 0 0 0 0 0 0 0
Arm/Group Title Group aP1 Group aP2 Group aP4 Group T5D2aP1 Group T5D2aP2 Group T5D2aP4 Group T5D4aP1 Group T5D4aP2 Group T5D4aP4 Licensed Tdap Total
Hide Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 27 36 32 27 33 30 37 30 30 33 315
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 36 participants 32 participants 27 participants 33 participants 30 participants 37 participants 30 participants 30 participants 33 participants 315 participants
30.2  (5.7) 29.5  (4.9) 30.3  (6.4) 31.3  (6.3) 30.9  (5.7) 30  (5.6) 28.2  (4.4) 30.1  (4.6) 31.3  (5.9) 31.5  (6.7) 30.3  (5.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 36 participants 32 participants 27 participants 33 participants 30 participants 37 participants 30 participants 30 participants 33 participants 315 participants
Female
17
  63.0%
25
  69.4%
19
  59.4%
11
  40.7%
19
  57.6%
16
  53.3%
27
  73.0%
13
  43.3%
19
  63.3%
21
  63.6%
187
  59.4%
Male
10
  37.0%
11
  30.6%
13
  40.6%
16
  59.3%
14
  42.4%
14
  46.7%
10
  27.0%
17
  56.7%
11
  36.7%
12
  36.4%
128
  40.6%
1.Primary Outcome
Title Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1.
Hide Description

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.

Time Frame Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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
Arm/Group Title Group aP1 Group aP2 Group aP4 Licensed Tdap
Hide Arm/Group Description:
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.
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.
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.
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 Number of Participants Analyzed 27 34 32 32
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
PT
28
(18 to 44)
31
(21 to 46)
48
(32 to 72)
18
(12 to 27)
FHA
43
(31 to 59)
54
(41 to 71)
60
(45 to 80)
63
(47 to 84)
PRN
206
(138 to 308)
276
(193 to 394)
396
(274 to 572)
126
(87 to 182)
2.Primary Outcome
Title Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1.
Hide Description

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.

Time Frame Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis were done on per protocol set.
Arm/Group Title Group T5D2aP1 Group T5D2aP2 Group T5D2aP4 Licensed Tdap
Hide Arm/Group Description:
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.
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.
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.
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 Number of Participants Analyzed 26 31 28 32
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
PT
17
(12 to 24)
22
(15 to 31)
34
(24 to 48)
18
(13 to 25)
FHA
41
(29 to 56)
32
(24 to 44)
51
(37 to 69)
63
(47 to 84)
PRN
93
(59 to 146)
248
(165 to 375)
373
(242 to 575)
126
(84 to 189)
3.Primary Outcome
Title Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1.
Hide Description

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.

Time Frame Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis were done on per protocol set.
Arm/Group Title Group T5D4aP1 Group T5D4aP2 Group T5D4aP4 Licensed Tdap
Hide Arm/Group Description:
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.
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.
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.
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 Number of Participants Analyzed 33 28 29 32
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
PT
31
(22 to 43)
31
(21 to 44)
43
(30 to 61)
18
(13 to 25)
FHA
51
(38 to 67)
48
(35 to 65)
58
(43 to 78)
63
(47 to 84)
PRN
247
(166 to 368)
266
(172 to 410)
292
(191 to 448)
126
(84 to 189)
4.Primary Outcome
Title Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Hide Description

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.

Time Frame Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group aP1 Group aP2 Group aP4 Licensed Tdap
Hide Arm/Group Description:
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.
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.
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.
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 Number of Participants Analyzed 27 34 32 32
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratios
Day 1 of V113_01E1/ Day 1 of V113_01 (PT)
7.21
(4.77 to 11)
7.63
(5.29 to 11)
11
(7.48 to 16)
4.28
(2.93 to 6.25)
Day 1 of V113_01E1/ Day 8 of V113_01 (PT)
2.93
(1.83 to 4.69)
1.50
(0.99 to 2.28)
1.60
(1.04 to 2.46)
1.00
(0.65 to 1.54)
Day 1 of V113_01E1/ Day 30 of V113_01 (PT)
0.30
(0.24 to 0.38)
0.24
(0.20 to 0.30)
0.26
(0.21 to 0.32)
0.21
(0.17 to 0.26)
Day 1 of V113_01E1/ Day 180 of V113_01 (PT)
0.48
(0.41 to 0.56)
0.45
(0.39 to 0.52)
0.42
(0.36 to 0.48)
0.42
(0.36 to 0.49)
Day 1 of V113_01E1/ Day 365 of V113_01 (PT)
0.68
(0.59 to 0.79)
0.63
(0.55 to 0.72)
0.56
(0.49 to 0.64)
0.67
(0.59 to 0.77)
Day 1 of V113_01E1/ Day 1 of V113_01 (FHA)
2.25
(1.67 to 3.05)
3.25
(2.49 to 4.25)
2.75
(2.09 to 3.63)
3.36
(2.55 to 4.44)
Day 1 of V113_01E1/ Day 8 of V113_01 (FHA)
1.06
(0.77 to 1.46)
1.00
(0.75 to 1.32)
0.93
(0.69 to 1.24)
0.62
(0.46 to 0.83)
Day 1 of V113_01E1/ Day 30 of V113_01 (FHA)
0.39
(0.30 to 0.50)
0.34
(0.27 to 0.43)
0.32
(0.25 to 0.40)
0.26
(0.21 to 0.33)
Day 1 of V113_01E1/ Day 180 of V113_01 (FHA)
0.64
(0.54 to 0.77)
0.69
(0.58 to 0.81)
0.65
(0.55 to 0.77)
0.54
(0.45 to 0.63)
Day 1 of V113_01E1/ Day 365 of V113_01 (FHA)
0.83
(0.70 to 0.98)
0.95
(0.82 to 1.10)
0.78
(0.67 to 0.91)
0.79
(0.68 to 0.92)
Day 1 of V113_01E1/ Day 1 of V113_01 (PRN)
11
(6.75 to 17)
15
(10 to 23)
20
(13 to 31)
6.61
(4.36 to 10)
Day 1 of V113_01E1/ Day 8 of V113_01 (PRN)
1.66
(1.12 to 2.45)
1.31
(0.92 to 1.85)
0.85
(0.59 to 1.22)
0.88
(0.61 to 1.26)
Day 1 of V113_01E1/ Day 30 of V113_01 (PRN)
0.33
(0.26 to 0.41)
0.30
(0.24 to 0.36)
0.27
(0.22 to 0.33)
0.29
(0.24 to 0.36)
Day 1 of V113_01E1/ Day 180 of V113_01 (PRN)
0.45
(0.39 to 0.51)
0.47
(0.42 to 0.54)
0.47
(0.42 to 0.54)
0.48
(0.42 to 0.54)
Day 1 of V113_01E1/ Day 365 of V113_01 (PRN)
0.62
(0.55 to 0.70)
0.63
(0.56 to 0.70)
0.59
(0.53 to 0.66)
0.72
(0.64 to 0.80)
5.Primary Outcome
Title Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Hide Description

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.

Time Frame Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis were done on per protocol set
Arm/Group Title Group T5D2aP1 Group T5D2aP2 Group T5D2aP4 Licensed Tdap
Hide Arm/Group Description:
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.
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.
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.
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 Number of Participants Analyzed 26 31 28 32
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratios
Day 1 of V113_01E1/ Day 1 of V113_01 (PT)
3.70
(2.40 to 5.71)
3.58
(2.41 to 5.32)
6.67
(4.39 to 10)
4.28
(2.90 to 6.33)
Day 1 of V113_01E1/ Day 8 of V113_01 (PT)
1.05
(0.71 to 1.55)
1.03
(0.72 to 1.46)
0.80
(0.55 to 1.16)
1.00
(0.71 to 1.42)
Day 1 of V113_01E1/ Day 30 of V113_01 (PT)
0.30
(0.24 to 0.37)
0.30
(0.25 to 0.36)
0.26
(0.21 to 0.32)
0.21
(0.17 to 0.25)
Day 1 of V113_01E1/ Day 180 of V113_01 (PT)
0.44
(0.37 to 0.52)
0.47
(0.40 to 0.56)
0.41
(0.35 to 0.49)
0.42
(0.36 to 0.49)
Day 1 of V113_01E1/ Day 365 of V113_01 (PT)
0.70
(0.61 to 0.81)
0.63
(0.56 to 0.72)
0.61
(0.53 to 0.70)
0.67
(0.59 to 0.77)
Day 1 of V113_01E1/ Day 1 of V113_01 (FHA)
1.99
(1.46 to 2.71)
1.79
(1.35 to 2.39)
2.04
(1.51 to 2.75)
3.36
(2.54 to 4.45)
Day 1 of V113_01E1/ Day 8 of V113_01 (FHA)
0.94
(0.71 to 1.24)
0.78
(0.60 to 1.00)
0.84
(0.64 to 1.09)
0.62
(0.48 to 0.79)
Day 1 of V113_01E1/ Day 30 of V113_01 (FHA)
0.49
(0.37 to 0.64)
0.39
(0.31 to 0.51)
0.40
(0.31 to 0.52)
0.26
(0.21 to 0.34)
Day 1 of V113_01E1/ Day 180 of V113_01 (FHA)
0.76
(0.62 to 0.94)
0.63
(0.52 to 0.77)
0.66
(0.54 to 0.81)
0.54
(0.44 to 0.65)
Day 1 of V113_01E1/ Day 365 of V113_01 (FHA)
0.94
(0.77 to 1.13)
0.84
(0.70 to 1.00)
0.87
(0.72 to 1.05)
0.79
(0.67 to 0.94)
Day 1 of V113_01E1/ Day 1 of V113_01 (PRN)
7.65
(4.71 to 12)
10
(6.71 to 16)
11
(6.91 to 18)
6.61
(4.27 to 10)
Day 1 of V113_01E1/ Day 8 of V113_01 (PRN)
1.41
(0.96 to 2.06)
1.11
(0.78 to 1.57)
0.91
(0.63 to 1.32)
0.88
(0.62 to 1.24)
Day 1 of V113_01E1/ Day 30 of V113_01 (PRN)
0.35
(0.28 to 0.43)
0.32
(0.26 to 0.39)
0.30
(0.24 to 0.37)
0.29
(0.24 to 0.36)
Day 1 of V113_01E1/ Day 180 of V113_01 (PRN)
0.43
(0.36 to 0.50)
0.47
(0.41 to 0.55)
0.50
(0.43 to 0.59)
0.48
(0.41 to 0.55)
Day 1 of V113_01E1/ Day 365 of V113_01 (PRN)
0.70
(0.62 to 0.79)
0.60
(0.54 to 0.73)
0.59
(0.52 to 0.67)
0.72
(0.64 to 0.80)
6.Primary Outcome
Title Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Hide Description

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.

Time Frame Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group T5D4aP1 Group T5D4aP2 Group T5D4aP4 Licensed Tdap
Hide Arm/Group Description:
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.
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.
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.
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 Number of Participants Analyzed 33 28 29 32
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratios
Day 1 of V113_01E1/ Day 1 of V113_01 (PT)
3.40
(2.32 to 5.00)
3.82
(2.51 to 5.79)
5.90
(3.92 to 8.90)
4.28
(2.90 to 6.33)
Day 1 of V113_01E1/ Day 8 of V113_01 (PT)
1.02
(0.73 to 1.44)
0.98
(0.67 to 1.42)
1.11
(0.77 to 1.60)
1.00
(0.71 to 1.42)
Day 1 of V113_01E1/ Day 30 of V113_01 (PT)
0.37
(0.30 to 0.45)
0.32
(0.26 to 0.39)
0.32
(0.26 to 0.39)
0.21
(0.17 to 0.25)
Day 1 of V113_01E1/ Day 180 of V113_01 (PT)
0.60
(0.52 to 0.71)
0.44
(0.37 to 0.53)
0.48
(0.40 to 0.57)
0.42
(0.36 to 0.49)
Day 1 of V113_01E1/ Day 365 of V113_01 (PT)
0.81
(0.71 to 0.92)
0.64
(0.56 to 0.73)
0.65
(0.57 to 0.74)
0.67
(0.59 to 0.77)
Day 1 of V113_01E1/ Day 1 of V113_01 (FHA)
2.09
(1.58 to 2.75)
1.67
(1.23 to 2.25)
2.19
(1.63 to 2.94)
3.36
(2.54 to 4.45)
Day 1 of V113_01E1/ Day 8 of V113_01 (FHA)
0.85
(0.67 to 1.09)
0.82
(0.63 to 1.08)
0.99
(0.76 to 1.28)
0.62
(0.48 to 0.79)
Day 1 of V113_01E1/ Day 30 of V113_01 (FHA)
0.45
(0.36 to 0.58)
0.49
(0.38 to 0.64)
0.50
(0.39 to 0.65)
0.26
(0.21 to 0.34)
Day 1 of V113_01E1/ Day 180 of V113_01 (FHA)
0.78
(0.65 to 0.95)
0.72
(0.58 to 0.88)
0.79
(0.64 to 0.97)
0.54
(0.44 to 0.65)
Day 1 of V113_01E1/ Day 365 of V113_01 (FHA)
0.99
(0.84 to 1.18)
0.83
(0.69 to 1.00)
0.97
(0.81 to 1.17)
0.79
(0.67 to 0.94)
Day 1 of V113_01E1/ Day 1 of V113_01 (PRN)
8.76
(5.70 to 13)
12
(7.50 to 19)
13
(8.23 to 21)
6.61
(4.27 to 10)
Day 1 of V113_01E1/ Day 8 of V113_01 (PRN)
1.24
(0.88 to 1.73)
1.41
(0.98 to 2.03)
1.11
(0.77 to 1.59)
0.88
(0.62 to 1.24)
Day 1 of V113_01E1/ Day 30 of V113_01 (PRN)
0.33
(0.27 to 0.40)
0.37
(0.30 to 0.46)
0.33
(0.27 to 0.40)
0.29
(0.24 to 0.36)
Day 1 of V113_01E1/ Day 180 of V113_01 (PRN)
0.57
(0.49 to 0.66)
0.49
(0.41 to 0.57)
0.48
(0.41 to 0.56)
0.48
(0.41 to 0.55)
Day 1 of V113_01E1/ Day 365 of V113_01 (PRN)
0.67
(0.60 to 0.75)
0.64
(0.57 to 0.73)
0.58
(0.52 to 0.66)
0.72
(0.64 to 0.80)
Time Frame No Adverse Events data were collected in this study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group aP1 Group aP2 Group aP4 Group T5D2aP1 Group T5D2aP2 Group T5D2aP4 Group T5D4aP1 Group T5D4aP2 Group T5D4aP4 Licensed Tdap
Hide Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
All-Cause Mortality
Group aP1 Group aP2 Group aP4 Group T5D2aP1 Group T5D2aP2 Group T5D2aP4 Group T5D4aP1 Group T5D4aP2 Group T5D4aP4 Licensed Tdap
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group aP1 Group aP2 Group aP4 Group T5D2aP1 Group T5D2aP2 Group T5D2aP4 Group T5D4aP1 Group T5D4aP2 Group T5D4aP4 Licensed Tdap
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group aP1 Group aP2 Group aP4 Group T5D2aP1 Group T5D2aP2 Group T5D2aP4 Group T5D4aP1 Group T5D4aP2 Group T5D4aP4 Licensed Tdap
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT02382913     History of Changes
Other Study ID Numbers: V113_01E1
2014-003729-16 ( EudraCT Number )
First Submitted: February 27, 2015
First Posted: March 9, 2015
Results First Submitted: January 14, 2016
Results First Posted: February 12, 2016
Last Update Posted: March 24, 2016