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Safety and Dose Ranging Study of Acellular Pertussis and Acellular Pertussis -Tetanus-Diphtheria Booster Vaccines in Healthy Adults Ages 18 to 40 Years

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ClinicalTrials.gov Identifier: NCT01529645
Recruitment Status : Completed
First Posted : February 9, 2012
Results First Posted : September 18, 2014
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions Pertussis
Whooping Cough
Tetanus
Lockjaw
Diphtheria
Interventions Biological: Acellular pertussis vaccine
Biological: Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed)
Biological: Licensed TdaP booster vaccine
Biological: Diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany)
Other: Saline solution
Enrollment 420

Recruitment Details  
Pre-assignment Details  
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 day 1 of this study. Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study. Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study. Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on day 1 of this study. Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study. Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study. Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study. Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study. Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study. Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
Period Title: Overall Study
Started 42 42 42 42 42 42 42 42 42 42
Completed 40 41 40 40 40 41 40 42 41 42
Not Completed 2 1 2 2 2 1 2 0 1 0
Reason Not Completed
Lost to Follow-up             0             1             1             1             1             0             2             0             1             0
SAE - Premature contractions             0             0             1             0             0             0             0             0             0             0
Withdrawal by Subject             2             0             0             1             1             1             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 day 1 of this study. Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study. Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study. Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study. Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study. Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study. Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study. Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study. Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study. Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study. Total of all reporting groups
Overall Number of Baseline Participants 42 42 42 42 42 42 42 42 42 42 420
Hide Baseline Analysis Population Description
Analysis was done on the all enrolled set, ie, all subjects who have signed an informed consent, undergone screening procedures and were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 42 participants 42 participants 42 participants 42 participants 42 participants 42 participants 42 participants 42 participants 42 participants 420 participants
26.6  (5.6) 26.8  (5.1) 27.4  (6.5) 26.8  (5.7) 27.7  (5.9) 25.8  (5.2) 25.1  (4.2) 27.5  (5.1) 27.2  (5.6) 27.4  (6.4) 26.8  (5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 42 participants 42 participants 42 participants 42 participants 42 participants 42 participants 42 participants 42 participants 420 participants
Female
24
  57.1%
28
  66.7%
25
  59.5%
23
  54.8%
27
  64.3%
24
  57.1%
29
  69.0%
19
  45.2%
27
  64.3%
24
  57.1%
250
  59.5%
Male
18
  42.9%
14
  33.3%
17
  40.5%
19
  45.2%
15
  35.7%
18
  42.9%
13
  31.0%
23
  54.8%
15
  35.7%
18
  42.9%
170
  40.5%
1.Primary Outcome
Title The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
Hide Description The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed and compared to that of licensed comparator in terms of the number of subjects reporting solicited local and systemic adverse events and other adverse events after vaccination.
Time Frame Day 1 through 7 after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the safety set, ie, all subjects who received the study vaccination and provided post vaccination safety data.
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 day 1 of this study.
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
Overall Number of Participants Analyzed 42 42 41 42 42 42 41 42 42 42
Measure Type: Number
Unit of Measure: participants
Any local 30 33 32 35 38 37 40 36 39 33
Injection site erythema 0 1 1 1 2 6 3 2 4 3
Injection site induration 3 3 1 6 1 7 9 4 4 6
Injection site pruritus 0 4 1 3 2 5 3 3 6 5
Injection site pain 30 32 31 35 38 36 40 35 39 31
Any Systemic 27 20 20 18 20 23 27 21 27 21
Nausea 3 6 2 1 2 5 4 6 7 1
Fatigue 19 14 13 13 15 18 20 15 16 12
Generalized myalgia 10 8 4 8 10 11 12 8 9 11
Generalized arthralgia 2 0 3 4 1 3 4 4 7 1
Headache 17 13 12 8 13 13 16 14 17 13
Any Other 6 7 2 6 8 4 8 7 7 8
Body temperature (≥40°C) 0 0 0 0 0 0 0 0 0 0
Prophylactic use of analgesic/antipyretic 0 1 0 0 1 1 2 1 2 1
Therapeutic use of analgesic/antipyretic 6 7 2 6 8 3 8 7 7 8
2.Primary Outcome
Title The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
Hide Description The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed in terms of the number of subjects reporting any unsolicited adverse events (AEs) between day 1 to day 30 , serious adverse events (SAEs) and AEs leading to premature withdrawal between day 1 to day 365, after vaccination.
Time Frame From day 1 to day 365
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the safety set.
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 day 1 of this study.
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
Overall Number of Participants Analyzed 42 42 41 42 42 42 41 42 42 42
Measure Type: Number
Unit of Measure: participants
Any AE (day 1 to 30) 20 28 12 21 13 17 16 14 18 18
At least possibly related unsolicited AEs 11 13 7 8 9 11 7 4 11 10
Any SAE (Day1 to Day 365) 4 1 1 1 0 1 1 2 2 1
At least possibly related SAEs 0 0 0 0 0 0 0 0 0 0
AEs leading to withdrawal (Day1 to Day 365) 0 0 0 0 0 0 0 0 0 0
Death 0 0 0 0 0 0 0 0 0 0
3.Primary Outcome
Title Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination
Hide Description The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) on aP booster groups, against pertussis antigens pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), following vaccination with different antigenic formulations of aP versus the response to the commercially available comparator are reported.
Time Frame Day 1 (baseline) and Day 30 post vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the per-protocol population, ie, all subjects who correctly received the vaccine, and provided evaluable serum samples at the relevant time points and had no major protocol violation as defined prior to unblinding.
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 day 1 of this study.
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
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 day1 of this study.
Overall Number of Participants Analyzed 42 38 39 40
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Day 1 (PT)
4.92
(3.22 to 7.53)
3.81
(2.43 to 5.95)
4.23
(2.72 to 6.57)
5.07
(3.28 to 7.84)
Day 30 (PT; N= 39,35,36,40)
91
(67 to 122)
145
(106 to 199)
182
(133 to 249)
87
(65 to 117)
Day 1 (FHA)
20
(15 to 27)
16
(11 to 22)
21
(15 to 29)
20
(15 to 28)
Day 30 (FHA; N= 39,35,36,40)
114
(93 to 140)
147
(119 to 182)
183
(148 to 226)
241
(198 to 294)
Day 1 (PRN)
20
(14 to 28)
16
(11 to 23)
17
(12 to 25)
21
(14 to 31)
Day 30 (PRN; N= 39,35,36,40)
589
(440 to 788)
936
(687 to 1273)
1384
(1020 to 1878)
475
(356 to 635)
4.Primary Outcome
Title GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination
Hide Description The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP Booster Groups against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported.
Time Frame Day 1 (baseline) and Day 30 post vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the per-protocol population.
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 and a fixed dose of tetanus toxoid) on day 1 of this 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 day 1 of this 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 day 1 of this 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 day1 of this study.
Overall Number of Participants Analyzed 41 38 40 40
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Day 1 (PT)
4.35
(2.86 to 6.6)
4.97
(3.22 to 7.67)
4.8
(3.15 to 7.32)
5.07
(3.32 to 7.73)
Day 30 (PT; N= 41,38,38,40)
62
(49 to 80)
72
(56 to 93)
160
(124 to 206)
86
(68 to 110)
Day 1 (FHA)
20
(14 to 28)
16
(12 to 23)
23
(17 to 33)
20
(15 to 28)
Day 30 (FHA; N= 41,38,38,40)
83
(69 to 100)
90
(74 to 109)
118
(97 to 143)
241
(200 to 291)
Day 1 (PRN)
13
(8.72 to 21)
21
(13 to 32)
27
(17 to 41)
21
(14 to 32)
Day 30 (PRN; N= 41,38,38,40)
445
(317 to 626)
803
(567 to 1138)
1092
(766 to 1555)
496
(353 to 696)
5.Primary Outcome
Title GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination
Hide Description The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP booster groups, against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported.
Time Frame Day 1 (baseline) and Day 30 post vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the per-protocol population.
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 day 1 of this 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 day 1 of this 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 day 1 of this 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 day 1 of this study.
Overall Number of Participants Analyzed 37 39 40 40
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Day 1 (PT)
8.74
(5.64 to 14)
8.2
(5.32 to 13)
8.06
(5.25 to 12)
5.07
(3.3 to 7.78)
Day 30 (PT)
83
(64 to 108)
93
(72 to 120)
157
(122 to 202)
93
(72 to 119)
Day 1 (FHA)
24
(17 to 33)
27
(20 to 38)
26
(18 to 36)
20
(15 to 28)
Day 30 (FHA)
116
(96 to 140)
100
(83 to 121)
113
(94 to 135)
252
(210 to 303)
Day 1 (PRN)
30
(20 to 47)
22
(14 to 34)
28
(19 to 43)
21
(14 to 32)
Day 30 (PRN)
837
(624 to 1124)
680
(510 to 906)
1024
(772 to 1359)
506
(381 to 671)
6.Primary Outcome
Title Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens
Hide Description The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for different antigenic formulations of aP booster vaccines and for licensed comparator are reported.
Time Frame Day 30 post vaccination/baseline (Day 1)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the per-protocol population.
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 day 1 of this study.
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
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 day1 of this study.
Overall Number of Participants Analyzed 39 35 36 40
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
Day 30/Day 1 (PT)
18
(12 to 26)
36
(24 to 54)
49
(33 to 73)
17
(12 to 25)
Day 30/Day 1 (FHA)
5.49
(3.99 to 7.54)
9.42
(6.74 to 13)
9.39
(6.75 to 13)
12
(8.73 to 16)
Day 30/Day 1 (PRN)
30
(21 to 44)
58
(39 to 86)
81
(54 to 119)
24
(16 to 34)
7.Primary Outcome
Title GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens
Hide Description The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported.
Time Frame Day 30 post vaccination/baseline (Day 1)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the per-protocol population.
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 and a fixed dose of tetanus toxoid) on day 1 of this 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 day 1 of this 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 day 1 of this 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 day1 of this study.
Overall Number of Participants Analyzed 41 38 38 40
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
Day 30/Day 1 (PT)
14
(9.58 to 21)
15
(10 to 23)
31
(21 to 46)
17
(12 to 26)
Day 30/Day 1 (FHA)
4.24
(3.21 to 5.6)
5.02
(3.76 to 6.71)
5.11
(3.83 to 6.83)
12
(9.01 to 16)
Day 30/Day 1 (PRN)
30
(21 to 45)
38
(25 to 57)
46
(31 to 69)
24
(16 to 35)
8.Primary Outcome
Title GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens
Hide Description The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported.
Time Frame Day 30 post vaccination/baseline (Day 1)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the per-protocol population.
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 day 1 of this 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 day 1 of this 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 day 1 of this 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 day 1 of this study.
Overall Number of Participants Analyzed 37 39 40 40
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
Day 30/Day 1 (PT)
9.51
(6.38 to 14)
12
(7.9 to 17)
20
(14 to 29)
17
(12 to 25)
Day 30/Day 1 (FHA)
4.7
(3.47 to 6.38)
3.95
(2.94 to 5.31)
4.39
(3.28 to 5.89)
12
(8.91 to 16)
Day 30/Day 1 (PRN)
27
(18 to 42)
32
(21 to 48)
36
(24 to 54)
24
(16 to 36)
9.Primary Outcome
Title Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination
Hide Description The percentages of subjects demonstrating diphtheria and tetanus antitoxin units >= 0.1/mL following vaccination with different antigenic formulations of TdaP booster vaccine, is compared to the response to commercially available comparator.
Time Frame Day 1 (baseline) and Day 30 post vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the per-protocol population.
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 day 1 of this study.
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
Overall Number of Participants Analyzed 39 35 36 41 38 38 37 39 40 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentages of subjects
Day 1 (diphteria; N=42,38,39,41,38,40,37,39,40,40)
79
(63 to 90)
89
(75 to 97)
72
(55 to 85)
71
(54 to 84)
68
(51 to 82)
85
(70 to 94)
81
(65 to 92)
72
(55 to 85)
78
(62 to 89)
80
(64 to 91)
Day 30 (diphteria)
87
(73 to 96)
97
(85 to 100)
81
(64 to 92)
98
(87 to 100)
97
(86 to 100)
95
(82 to 99)
100
(91 to 100)
100
(91 to 100)
100
(91 to 100)
100
(91 to 100)
Day 1 (tetanus; N=42,38,39,41,38,40,37,39,40,40)
98
(87 to 100)
100
(91 to 100)
100
(91 to 100)
100
(91 to 100)
100
(91 to 100)
95
(83 to 99)
100
(91 to 100)
100
(91 to 100)
98
(87 to 100)
95
(83 to 99)
Day 30 (tetanus)
100
(91 to 100)
100
(90 to 100)
100
(90 to 100)
100
(91 to 100)
100
(91 to 100)
97
(86 to 100)
100
(91 to 100)
100
(91 to 100)
100
(91 to 100)
100
(91 to 100)
10.Secondary Outcome
Title Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination.
Hide Description Comparison of antibody responses against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of aP and TdaP booster vaccines and licensed comparator, are reported in terms of the percentages of subjects demonstrating 2- and 4-fold increase in GMCs from baseline.
Time Frame Day 30 post vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the per-protocol population.
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 day 1 of this study.
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
Overall Number of Participants Analyzed 39 35 36 41 38 38 37 39 40 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
2-Fold (PT)
100
(91 to 100)
100
(90 to 100)
94
(81 to 99)
95
(83 to 99)
95
(82 to 99)
100
(91 to 100)
89
(75 to 97)
90
(76 to 97)
95
(83 to 99)
100
(91 to 100)
4-Fold (PT)
92
(79 to 98)
100
(90 to 100)
92
(78 to 98)
80
(65 to 91)
76
(60 to 89)
100
(91 to 100)
81
(65 to 92)
77
(61 to 89)
93
(80 to 98)
98
(87 to 100)
2-Fold (FHA)
85
(69 to 94)
94
(81 to 99)
89
(74 to 97)
80
(65 to 91)
95
(82 to 99)
95
(82 to 99)
76
(59 to 88)
77
(61 to 89)
90
(76 to 97)
95
(83 to 99)
4-Fold (FHA)
59
(42 to 74)
83
(66 to 93)
83
(67 to 94)
46
(31 to 63)
61
(43 to 76)
58
(41 to 74)
46
(29 to 63)
56
(40 to 72)
53
(36 to 68)
83
(67 to 93)
2-Fold (PRN)
100
(91 to 100)
100
(90 to 100)
100
(90 to 100)
98
(87 to 100)
100
(91 to 100)
100
(91 to 100)
97
(86 to 100)
92
(79 to 98)
100
(91 to 100)
100
(91 to 100)
4-Fold (PRN)
92
(79 to 98)
100
(90 to 100)
100
(90 to 100)
90
(77 to 97)
95
(82 to 99)
97
(86 to 100)
89
(75 to 97)
85
(69 to 94)
98
(87 to 100)
90
(76 to 97)
11.Secondary Outcome
Title GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination
Hide Description The GMCs of antibodies against diphtheria and tetanus antigens following vaccination with different formulations of TdaP booster are compared with the response to the commercially available comparator.
Time Frame Day 1 (baseline) and Day 30 post vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the per-protocol population.
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 day 1 of this study.
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
Overall Number of Participants Analyzed 39 35 36 41 38 38 37 39 40 40
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Day 1 (diphteria; N=42,38,39,41,38,40,37,39,40,40)
0.4
(0.27 to 0.6)
0.43
(0.28 to 0.65)
0.25
(0.17 to 0.38)
0.31
(0.2 to 0.46)
0.15
(0.098 to 0.23)
0.29
(0.19 to 0.44)
0.31
(0.2 to 0.48)
0.25
(0.16 to 0.39)
0.25
(0.17 to 0.39)
0.3
(0.19 to 0.45)
Day 30 (diphteria)
0.39
(0.32 to 0.49)
0.39
(0.31 to 0.5)
0.37
(0.29 to 0.46)
1.48
(1.1 to 1.99)
1.41
(1.04 to 1.92)
1.63
(1.2 to 2.21)
2.7
(1.97 to 3.69)
2.19
(1.62 to 2.97)
2.47
(1.83 to 3.33)
1.79
(1.32 to 2.41)
Day 1 (tetanus; N=42,38,39,41,38,40,37,39,40,40)
2.45
(1.9 to 3.16)
2.11
(1.61 to 2.76)
2.27
(1.74 to 2.96)
1.93
(1.44 to 2.58)
1.99
(1.47 to 2.68)
2.07
(1.54 to 2.77)
2.04
(1.5 to 2.76)
2.62
(1.95 to 3.53)
1.92
(1.43 to 2.58)
1.89
(1.41 to 2.53)
Day 30 (tetanus)
2.19
(1.91 to 2.52)
2.18
(1.88 to 2.52)
2.19
(1.89 to 2.53)
8.15
(6.73 to 9.88)
8.82
(7.23 to 11)
7.01
(5.74 to 8.56)
8.23
(6.73 to 10)
6.82
(5.6 to 8.32)
7.44
(6.13 to 9.04)
8.49
(6.99 to 10)
12.Secondary Outcome
Title GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens
Hide Description The GMRs of post vaccination versus pre vaccination GMCs of antibodies against diphtheria and tetanus antigens for different formulations of TdaP booster and commercially available comparator versus GMCs at baseline are reported.
Time Frame Day 30 post vaccination/Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the per-protocol population.
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 day 1 of this study.
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
Overall Number of Participants Analyzed 39 35 36 41 38 38 37 39 40 40
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
Day 30/day 1 (diphtheria)
1.05
(0.94 to 1.16)
1.05
(0.93 to 1.17)
1.19
(1.07 to 1.33)
5.24
(3.66 to 7.49)
8.58
(5.91 to 12)
5.62
(3.87 to 8.16)
9.18
(6.3 to 13)
8.39
(5.81 to 12)
9.54
(6.64 to 14)
6.1
(4.25 to 8.78)
Day 30/day 1 (tetanus)
0.94
(0.88 to 1.02)
0.92
(0.86 to 1)
0.97
(0.9 to 1.04)
4.2
(3.01 to 5.86)
4.43
(3.14 to 6.26)
3.43
(2.43 to 4.84)
4.02
(2.83 to 5.71)
2.64
(1.88 to 3.71)
3.86
(2.76 to 5.41)
4.5
(3.21 to 6.3)
Time Frame Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Adverse Event Reporting Description Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
 
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 day 1 of this study. Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study. Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study. Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study. Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study. Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study. Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study. Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study. Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study. Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
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   4/42 (9.52%)   1/42 (2.38%)   1/41 (2.44%)   1/42 (2.38%)   0/42 (0.00%)   1/42 (2.38%)   1/41 (2.44%)   2/42 (4.76%)   2/42 (4.76%)   1/42 (2.38%) 
Cardiac disorders                     
Pericarditis * 1  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  0/42 (0.00%) 
Gastrointestinal disorders                     
Crohn's disease * 1  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  0/42 (0.00%) 
Infections and infestations                     
Peritonsillar abscess * 1  1/42 (2.38%)  0/42 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%) 
Appendicitis * 1  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%) 
Chronic sinusitis * 1  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/41 (2.44%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%) 
Gastroenteritis * 1  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%) 
Tonsillitis streptococcal * 1  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/42 (2.38%) 
Injury, poisoning and procedural complications                     
Ankle fracture * 1  1/42 (2.38%)  0/42 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%) 
Musculoskeletal and connective tissue disorders                     
Foot deformity * 1  1/42 (2.38%)  0/42 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%) 
Polymyalgia rheumatica * 1  0/42 (0.00%)  1/42 (2.38%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%) 
Pregnancy, puerperium and perinatal conditions                     
Premature labour * 1  0/42 (0.00%)  0/42 (0.00%)  1/41 (2.44%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%) 
Psychiatric disorders                     
Depression * 1  1/42 (2.38%)  0/42 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%) 
Dysthymic disorder * 1  1/42 (2.38%)  0/42 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%) 
Psychotic disorder * 1  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  0/42 (0.00%) 
Respiratory, thoracic and mediastinal disorders                     
Pneumothorax * 1  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  0/42 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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   36/42 (85.71%)   39/42 (92.86%)   36/41 (87.80%)   38/42 (90.48%)   41/42 (97.62%)   42/42 (100.00%)   40/41 (97.56%)   39/42 (92.86%)   40/42 (95.24%)   36/42 (85.71%) 
Blood and lymphatic system disorders                     
Lymphadenopathy * 1  1/42 (2.38%)  1/42 (2.38%)  1/41 (2.44%)  3/42 (7.14%)  0/42 (0.00%)  2/42 (4.76%)  2/41 (4.88%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%) 
Gastrointestinal disorders                     
Nausea  1  3/42 (7.14%)  6/42 (14.29%)  2/41 (4.88%)  2/42 (4.76%)  2/42 (4.76%)  5/42 (11.90%)  4/41 (9.76%)  6/42 (14.29%)  7/42 (16.67%)  1/42 (2.38%) 
General disorders                     
Axillary pain * 1  0/42 (0.00%)  1/42 (2.38%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  3/42 (7.14%)  0/41 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%) 
Fatigue  1  19/42 (45.24%)  14/42 (33.33%)  13/41 (31.71%)  13/42 (30.95%)  15/42 (35.71%)  18/42 (42.86%)  21/41 (51.22%)  15/42 (35.71%)  16/42 (38.10%)  12/42 (28.57%) 
Injection site erythema  1  0/42 (0.00%)  2/42 (4.76%)  1/41 (2.44%)  1/42 (2.38%)  1/42 (2.38%)  7/42 (16.67%)  2/41 (4.88%)  1/42 (2.38%)  4/42 (9.52%)  3/42 (7.14%) 
Injection site induration  1  2/42 (4.76%)  4/42 (9.52%)  1/41 (2.44%)  3/42 (7.14%)  1/42 (2.38%)  6/42 (14.29%)  8/41 (19.51%)  4/42 (9.52%)  3/42 (7.14%)  5/42 (11.90%) 
Injection site movement impairment * 1  2/42 (4.76%)  3/42 (7.14%)  2/41 (4.88%)  2/42 (4.76%)  2/42 (4.76%)  1/42 (2.38%)  3/41 (7.32%)  2/42 (4.76%)  0/42 (0.00%)  1/42 (2.38%) 
Injection site pain  1  30/42 (71.43%)  32/42 (76.19%)  31/41 (75.61%)  35/42 (83.33%)  38/42 (90.48%)  36/42 (85.71%)  40/41 (97.56%)  35/42 (83.33%)  39/42 (92.86%)  31/42 (73.81%) 
Injection site pruritus  1  0/42 (0.00%)  4/42 (9.52%)  1/41 (2.44%)  3/42 (7.14%)  2/42 (4.76%)  5/42 (11.90%)  3/41 (7.32%)  3/42 (7.14%)  6/42 (14.29%)  5/42 (11.90%) 
Pyrexia  1  1/42 (2.38%)  0/42 (0.00%)  2/41 (4.88%)  2/42 (4.76%)  1/42 (2.38%)  1/42 (2.38%)  3/41 (7.32%)  2/42 (4.76%)  0/42 (0.00%)  2/42 (4.76%) 
Infections and infestations                     
Upper respiratory tract infection * 1  5/42 (11.90%)  5/42 (11.90%)  2/41 (4.88%)  4/42 (9.52%)  1/42 (2.38%)  3/42 (7.14%)  3/41 (7.32%)  2/42 (4.76%)  0/42 (0.00%)  0/42 (0.00%) 
Musculoskeletal and connective tissue disorders                     
Arthralgia * 1  2/42 (4.76%)  0/42 (0.00%)  3/41 (7.32%)  4/42 (9.52%)  1/42 (2.38%)  3/42 (7.14%)  5/41 (12.20%)  4/42 (9.52%)  8/42 (19.05%)  2/42 (4.76%) 
Myalgia  1  10/42 (23.81%)  9/42 (21.43%)  4/41 (9.76%)  8/42 (19.05%)  10/42 (23.81%)  12/42 (28.57%)  14/41 (34.15%)  8/42 (19.05%)  9/42 (21.43%)  11/42 (26.19%) 
Nervous system disorders                     
Headache  1  19/42 (45.24%)  15/42 (35.71%)  13/41 (31.71%)  9/42 (21.43%)  14/42 (33.33%)  13/42 (30.95%)  16/41 (39.02%)  15/42 (35.71%)  19/42 (45.24%)  13/42 (30.95%) 
Respiratory, thoracic and mediastinal disorders                     
Oropharyngeal pain * 1  0/42 (0.00%)  0/42 (0.00%)  0/41 (0.00%)  1/42 (2.38%)  4/42 (9.52%)  0/42 (0.00%)  2/41 (4.88%)  3/42 (7.14%)  1/42 (2.38%)  0/42 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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.
Results Point of Contact
Name/Title: Posting Director
Organization: Novartis Vaccines
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01529645     History of Changes
Other Study ID Numbers: V113_01
2011-000688-28 ( EudraCT Number )
First Submitted: February 6, 2012
First Posted: February 9, 2012
Results First Submitted: April 30, 2014
Results First Posted: September 18, 2014
Last Update Posted: April 4, 2016