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

• 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: Novartis
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Group aP1	Group aP2	Group aP4	Group T5D2aP1	Group T5D2aP2	Group T5D2aP4	Group T5D4aP1	Group T5D4aP2	Group T5D4aP4	Licensed Tdap	Total
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
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%

Outcome Measures

1. Primary Outcome

Title	Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1.
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

Outcome Measure Data

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
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.
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

Outcome Measure Data

Analysis Population Description

Analysis were done on per protocol set.

Arm/Group Title	Group T5D2aP1	Group T5D2aP2	Group T5D2aP4	Licensed Tdap
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.
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

Outcome Measure Data

Analysis Population Description

Analysis were done on per protocol set.

Arm/Group Title	Group T5D4aP1	Group T5D4aP2	Group T5D4aP4	Licensed Tdap
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.
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

Outcome Measure Data

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
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.
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

Outcome Measure Data

Analysis Population Description

Analysis were done on per protocol set

Arm/Group Title	Group T5D2aP1	Group T5D2aP2	Group T5D2aP4	Licensed Tdap
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.
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

Outcome Measure Data

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
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)

Adverse Events

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
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	--/--	--/--	--/--	--/--	--/--	--/--	--/--	--/--	--/--	--/--
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
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

Limitations and Caveats

[Not Specified]

More Information

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
• EMail: RegistryContactVaccinesUS@novartis.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Leroux-Roels G, Lattanzi M, Solis CD, Contorni M, Costantini M, Moraschini L, Bardelli M, Bertholet S, Borgogni E, Buricchi F, Cantisani R, Faenzi E, Finco O, Leuzzi R, Pizza M, Rosa D, Schiavetti F, Seubert A, Spensieri F, Volpini G, Zedda L, Giudice GD, Galgani I. A phase I, randomized, controlled, dose-ranging study of investigational acellular pertussis (aP) and reduced tetanus-diphtheria-acellular pertussis (TdaP) booster vaccines in adults. Hum Vaccin Immunother. 2018 Jan 2;14(1):45-58. doi: 10.1080/21645515.2017.1385686. Epub 2017 Nov 27.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT02382913
• 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