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Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years

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ClinicalTrials.gov Identifier: NCT00329901
Recruitment Status : Completed
First Posted : May 25, 2006
Results First Posted : June 18, 2014
Last Update Posted : June 18, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Meningococcal Disease
Meningococcal Meningitis
Interventions Biological: Meningococcal ACWY conjugate vaccine (MenACWY-CRM)
Biological: Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap)
Biological: saline placebo
Enrollment 1072
Recruitment Details Subjects were recruited from 14 centers in Italy.
Pre-assignment Details All enrolled subjects participated in the trial.
Arm/Group Title Tdap + MenACWY-CRM Tdap + Saline MenACWY-CRM + Saline
Hide Arm/Group Description Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms Subjects received Tdap vaccine and saline (placebo)concomitantly, in separate arms Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
Period Title: Overall Study
Started 361 354 357
Completed 352 349 353
Not Completed 9 5 4
Reason Not Completed
Withdrawal by Subject             4             3             2
Lost to Follow-up             2             0             1
Protocol Violation             1             0             1
Unable to classify             2             2             0
Arm/Group Title Tdap + MenACWY-CRM Tdap + Saline MenACWY-CRM + Saline Total
Hide Arm/Group Description Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms Total of all reporting groups
Overall Number of Baseline Participants 361 354 357 1072
Hide Baseline Analysis Population Description
Baseline Characteristics are summarized for all enrolled population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 361 participants 354 participants 357 participants 1072 participants
14.4  (3.4) 14.1  (3.2) 14.3  (3.2) 14.3  (3.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 361 participants 354 participants 357 participants 1072 participants
Female
189
  52.4%
164
  46.3%
165
  46.2%
518
  48.3%
Male
172
  47.6%
190
  53.7%
192
  53.8%
554
  51.7%
1.Primary Outcome
Title Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
Hide Description

To demonstrate that the immunogenicity of one injection of Tdap vaccine, concomitantly administered with MenACWY-CRM vaccine, is not inferior to that of one injection of Tdap vaccine, concomitantly administered with saline placebo, in terms of

  1. the percentage of subjects with antibody levels against diphtheria toxin ≥ 1.0 IU/mL and against tetanus toxin ≥ 1.0 IU/mL and
  2. the percentage of subjects with at least 4 fold increase in antibody levels against pertussis toxin (PT), filamentous hemagglutinin (FHA) and pertactin (PRN) at 1 month after immunization, as measured by enzyme linked immunosorbent assay (ELISA).
Time Frame 1 month after vaccination (Day 29)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the per-protocol population i.e all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding
Arm/Group Title Tdap+MenACWY-CRM Tdap+Saline
Hide Arm/Group Description:
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
Overall Number of Participants Analyzed 350 345
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Day 1 (diphtheria)
4
(2 to 7)
5
(3 to 7)
Day 29 (diphtheria)
94
(91 to 96)
85
(80 to 88)
Day 1 (tetanus )
25
(20 to 30)
36
(31 to 42)
Day 29 (tetanus )
100
(99 to 100)
99
(98 to 100)
Day 29 (PT) 4-fold increase (N=286, 287)
76
(70 to 80)
81
(76 to 85)
Day 29 (FHA)4-fold increase (N=286, 287)
83
(78 to 87)
86
(82 to 90)
Day 29 (PRN) 4-fold increase (N=285, 287)
84
(79 to 88)
91
(87 to 94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tdap+MenACWY-CRM, Tdap+Saline
Comments Non-inferiority of anti-diphtheria immune response following concomitant administration of Tdap with MenACWY-CRM as compared to Tdap given with placebo saline
Type of Statistical Test Non-Inferiority or Equivalence
Comments The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference [(Tdap + MenACWY-CRM) minus(Tdap + saline)] was greater than -10, at 1 month (Day 29) after vaccination
Method of Estimation Estimation Parameter Vaccine Group difference
Estimated Value 9
Confidence Interval (2-Sided) 95%
5 to 14
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tdap+MenACWY-CRM, Tdap+Saline
Comments Non-inferiority of anti-tetanus immune response following concomitant administration of Tdap with MenACWY-CRM compared to Tdap given concomitantly with saline placebo
Type of Statistical Test Non-Inferiority or Equivalence
Comments The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference [(Tdap + MenACWY-CRM) minus(Tdap + saline)] was greater than -10, at 1 month (Day 29) after vaccination
Method of Estimation Estimation Parameter Vaccine Group Difference
Estimated Value 1
Confidence Interval (2-Sided) 95%
-1 to 2
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tdap+MenACWY-CRM, Tdap+Saline
Comments Non-inferiority of anti-PT antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo
Type of Statistical Test Non-Inferiority or Equivalence
Comments The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference [(Tdap + MenACWY-CRM) minus (Tdap + saline)] was greater than -10, at 1 month (Day 29) after vaccination
Method of Estimation Estimation Parameter Vaccine Group difference
Estimated Value -5
Confidence Interval (2-Sided) 95%
-12 to 1
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tdap+MenACWY-CRM, Tdap+Saline
Comments Non-inferiority of anti-FHA antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo
Type of Statistical Test Non-Inferiority or Equivalence
Comments The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference [(Tdap + MenACWY-CRM) minus (Tdap + saline)] was greater than -10, at 1 month (Day 29) after vaccination
Method of Estimation Estimation Parameter Vaccine Group Difference
Estimated Value -3
Confidence Interval (2-Sided) 95%
-9 to 3
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tdap+MenACWY-CRM, Tdap+Saline
Comments Non-inferiority of anti-PRN antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo
Type of Statistical Test Non-Inferiority or Equivalence
Comments The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference [(Tdap + MenACWY-CRM) minus (Tdap + saline)] was greater than -10, at 1 month (Day 29) after vaccination
Method of Estimation Estimation Parameter Vaccine Group Difference
Estimated Value -7
Confidence Interval (2-Sided) 95%
-13 to -2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo
Hide Description The percentage of subjects with anti-diphtheria and anti-tetanus concentrations ≥ 0.1 IU/mL (as measured by ELISA) following concomitant administration of Tdap vaccine with MenACWY-CRM vaccine as compared to when Tdap was given concomitantly with saline placebo.
Time Frame 1 month after vaccination (Day 29)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on per-protocol population.
Arm/Group Title Tdap+MenACWY-CRM Tdap+Saline
Hide Arm/Group Description:
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
Overall Number of Participants Analyzed 350 345
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Day 1 (diphtheria)
55
(50 to 60)
63
(57 to 68)
Day 29 (diphtheria)
100
(99 to 100)
100
(98 to 100)
Day 1 (tetanus)
97
(95 to 99)
97
(95 to 99)
Day 29 (tetanus)
100
(99 to 100)
100
(99 to 100)
3.Secondary Outcome
Title Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
Hide Description The geometric mean concentrations of antibodies ≥ 0.1 IU/mL against diphtheria, tetanus and pertussis (PT, FHA and PRN) antigens in subjects, as measured by ELISA, following concomitant administration of Tdap with MenACWY-CRM as compared to when Tdap given concomitantly with saline placebo.
Time Frame 1 month after vaccination (Day 29)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on per-protocol population.
Arm/Group Title Tdap+ MenACWY-CRM Tdap+Saline
Hide Arm/Group Description:
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
Overall Number of Participants Analyzed 350 345
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Day 1 (diptheria)
0.11
(0.085 to 0.14)
0.12
(0.096 to 0.16)
Day 29 (diptheria)
7.96
(6.19 to 10)
2.77
(2.15 to 3.57)
Day 1 (tetanus)
0.62
(0.5 to 0.76)
0.75
(0.61 to 0.92)
Day 29 (tetanus)
12
(9.84 to 14)
15
(13 to 18)
Day 1 (PT ) (N=286,287)
2.68
(1.97 to 3.66)
2.85
(2.1 to 3.86)
Day 29 (PT) (N=286,287)
62
(52 to 74)
79
(66 to 93)
Day 1 (FHA) (N=286,287)
15
(13 to 18)
17
(14 to 20)
Day 29 (FHA) (N=286,287)
186
(165 to 209)
219
(194 to 246)
Day 1 (PRN) (N=285,287)
6.45
(5.18 to 8.03)
8.7
(7.01 to 11)
Day 29 (PRN) (N=285,287)
157
(131 to 189)
254
(211 to 304)
4.Secondary Outcome
Title Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo
Hide Description The geometric mean ratios (GMRs- day 29/day 1) of post-vaccination versus pre- vaccination antibody concentrations against diptheria, tetanus and pertussis (PT, FHA and PRN) antigens following concomitant administration of Tdap vaccine with MenACWY-CRM vaccine as compared to when Tdap was given concomitantly with saline placebo.
Time Frame 1 month after vaccination (Day 29)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on per-protocol population.
Arm/Group Title Tdap+ MenACWY-CRM Tdap+Saline
Hide Arm/Group Description:
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
Overall Number of Participants Analyzed 350 345
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
diphtheria
72
(58 to 91)
22
(18 to 28)
tetanus
19
(14 to 25)
20
(15 to 26)
PT (N=286,287)
23
(18 to 30)
28
(21 to 36)
FHA (N=286,287)
12
(10 to 14)
13
(11 to 15)
PRN (N=285,287)
24
(20 to 30)
29
(24 to 35)
5.Secondary Outcome
Title Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Hide Description

The percentage of subjects with serum bactericidal antibody titers(hSBA) ≥ 1:4 and ≥ 1:8 against Neisseria meningitidis serogroups A,C,W and Y,following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo.

The serum bactericidal antibodies directed against N.meningitidis serogroup A, C, W and Y, are measured by human complement Serum Bactericidal Assay (hSBA).

Time Frame 1 month after vaccination (Day 29)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on per-protocol population.
Arm/Group Title Tdap + MenACWY-CRM MenACWY-CRM + Saline
Hide Arm/Group Description:
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
Overall Number of Participants Analyzed 119 126
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Day 1 (Men A) hSBA ≥ 1:4
3
(1 to 7)
5
(2 to 10)
Day 29 (Men A) hSBA ≥ 1:4
79
(71 to 86)
83
(75 to 89)
Day 1 (Men C) hSBA ≥ 1:4 (N=118,124)
36
(28 to 46)
30
(22 to 39)
Day 29 (Men C) hSBA ≥ 1:4 (N=118,124)
94
(88 to 98)
90
(84 to 95)
Day 1 (Men W) hSBA ≥ 1:4 (N=116,124)
57
(47 to 66)
56
(47 to 65)
Day 29 (Men W) hSBA ≥ 1:4 (N=116,124)
97
(93 to 99)
97
(92 to 99)
Day 1 (Men Y) hSBA ≥ 1:4 (N=117,125)
47
(38 to 56)
42
(33 to 51)
Day 29 (Men Y) hSBA ≥ 1:4 (N=117,125)
96
(90 to 99)
97
(92 to 99)
Day 1 (Men A) hSBA ≥ 1:8
2
(0 to 6)
4
(1 to 9)
Day 29 (Men A) hSBA ≥ 1:8
74
(65 to 82)
80
(72 to 87)
Day 1 (Men C) hSBA ≥ 1:8 (N=118,124)
25
(17 to 33)
25
(18 to 34)
Day 29 (Men C) hSBA ≥ 1:8 (N=118,124)
92
(86 to 96)
88
(81 to 93)
Day 1 (Men W) hSBA ≥ 1:8 (N=116,124)
53
(43 to 62)
56
(46 to 65)
Day 29 (Men W) hSBA ≥ 1:8 (N=116,124)
96
(90 to 99)
97
(92 to 99)
Day 1 (Men Y) hSBA ≥ 1:8 (N=117,125)
38
(30 to 48)
38
(29 to 47)
Day 29 (Men Y) hSBA ≥ 1:8 (N=117,125)
93
(87 to 97)
94
(89 to 98)
6.Secondary Outcome
Title The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Hide Description The hSBA geometric mean titers (GMTs) against N.meningitidis serogroups A,C,W and Y, at baseline and at one month, following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine, as compared to when MenACWY-CRM was given concomitantly with saline placebo.
Time Frame 1 month after vaccination (Day 29)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on per-protocol population.
Arm/Group Title Tdap + MenACWY-CRM MenACWY-CRM + Saline
Hide Arm/Group Description:
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
Overall Number of Participants Analyzed 119 126
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Day 1 (Men A)
2.14
(1.99 to 2.31)
2.21
(2.05 to 2.38)
Day 29 (Men A)
34
(23 to 50)
50
(34 to 74)
Day 1 (Men C) N=118,124
4
(3.23 to 4.96)
3.92
(3.16 to 4.86)
Day 29 (Men C) N=118,124
89
(58 to 136)
92
(60 to 140)
Day 1 (Men W) N=116,124
11
(7.7 to 15)
9.49
(6.93 to 13)
Day 29 (Men W) N=116,124
73
(54 to 98)
77
(57 to 103)
Day 1 (Men Y) N=117,125
5.38
(4.2 to 6.89)
5
(3.91 to 6.39)
Day 29 (Men Y) N=117,125
73
(54 to 98)
70
(52 to 94)
7.Secondary Outcome
Title Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Hide Description The geometric mean ratios (GMRs-day 29/day1)of post-vaccination versus pre- vaccination hSBA titers against N.meningitidis serogroups A,C,W and Y, when MenACWY-CRM vaccine is concomitantly administered with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo.
Time Frame 1 month after vaccination (Day 29)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on per-protocol population.
Arm/Group Title Tdap + MenACWY-CRM MenACWY-CRM + Saline
Hide Arm/Group Description:
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
Overall Number of Participants Analyzed 119 126
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratios
Men A
16
(11 to 23)
23
(16 to 33)
Men C (N=118,124)
22
(15 to 33)
23
(16 to 35)
Men W (N=116,124)
6.9
(4.84 to 9.85)
8.09
(5.69 to 12)
Men Y (N=117,125)
14
(9.41 to 19)
14
(9.79 to 20)
8.Secondary Outcome
Title Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Hide Description

The percentage of subjects showing an hSBA seroresponse against N.meningitidis serogroups A,C,W and Y, following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo.

Seroresponse to MenACWY-CRM is defined as a pre-vaccination hSBA titer < 1:4 to a post-vaccination hSBA titer of ≥ 1:8 or a pre-vaccination hSBA titer ≥ 1:4 to a post-vaccination titer of at least four times the baseline hSBA titer.

Time Frame 1 month after vaccination (Day 29)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on per-protocol population.
Arm/Group Title Tdap + MenACWY-CRM MenACWY-CRM + Saline
Hide Arm/Group Description:
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
Overall Number of Participants Analyzed 119 126
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Men A
74
(65 to 82)
80
(72 to 87)
Men C (N=118, 124)
82
(74 to 89)
78
(70 to 85)
Men W (N=116, 124)
58
(48 to 67)
59
(50 to 68)
Men Y (N=117, 125)
70
(61 to 78)
70
(61 to 78)
9.Secondary Outcome
Title Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo
Hide Description The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine and Tdap vaccine as compared to when MenACWY-CRM vaccine was concomitantly administered with saline placebo.
Time Frame Day 1-7 after any vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the safety population
Arm/Group Title Tdap + MenACWY-CRM MenACWY-CRM + Saline
Hide Arm/Group Description:
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
Overall Number of Participants Analyzed 359 357
Measure Type: Number
Unit of Measure: Participants
Local 278 179
Injection site pain (MenACWY) site 1 82 116
Injection site erythema (MenACWY) site 1 48 66
Injection site induration (MenACWY) site 1 41 59
Injection site pain (Tdap or saline) site 2 246 57
Injection site erythema (Tdap or saline) site 2 103 37
Injection site induration (Tdap or saline) site 2 118 23
Systemic 198 171
Chills 39 47
Nausea 43 28
Malaise 65 43
Myalgia 118 79
Arthralgia 57 40
Headache 129 128
Fever ≥ 38°C 11 14
Other 42 33
Stayed home due to reaction (N=358,357) 12 12
Analgesic Antipyretic medication used 38 31
10.Secondary Outcome
Title Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo
Hide Description The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine and Tdap vaccine as compared to when Tdap was concomitantly administered with saline placebo
Time Frame Day 1-7 after any vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the safety population
Arm/Group Title Tdap + MenACWY-CRM Tdap + Saline
Hide Arm/Group Description:
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
Overall Number of Participants Analyzed 359 353
Measure Type: Number
Unit of Measure: Participants
Local 278 282
Injection site pain (Tdap) site 2 227 246
Injection site erythema (Tdap) site 2 103 103
Injection site induration (Tdap) site 2 110 118
Injection site pain (MenACWY or saline) site 1 82 41
Injection site erythema (MenACWY or saline) site 1 48 34
Injection site induration(MenACWY or saline)site1 41 27
Systemic 198 202
Chills 39 41
Nausea 43 35
Malaise 65 57
Myalgia 118 127
Arthralgia 57 60
Headache 129 110
Fever ≥ 38°C 11 7
Other 42 39
Stayed home due to reaction (N=358,353) 12 15
Analgesic Antipyretic medication used 38 38
11.Secondary Outcome
Title Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo
Hide Description The number of subjects reporting any unsolicited adverse events (AEs) when Tdap is concomitantly administered with MenACWY-CRM as compared to when MenACWY-CRM vaccine or Tdap vaccine was concomitantly administered with saline placebo.
Time Frame Throughout the study (Day 1 to Day 181)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was done on the safety population.
Arm/Group Title Tdap + MenACWY-CRM Tdap + Saline MenACWY-CRM + Saline
Hide Arm/Group Description:
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
Overall Number of Participants Analyzed 359 353 357
Measure Type: Number
Unit of Measure: Participants
Any AE (Day 1 to 29) 43 31 48
Possibly/probably related AE (Day 1 to 29) 8 6 6
Serious AEs (Day 1 to 29) 0 0 0
AE's leading to discontinuation (Day 1 to 29) 0 0 0
Possibly/probably related SAE(Day 1 to 29) 0 0 0
Death ( Day 1 to 29) 0 0 0
Any AE (Day 30 to 181) 42 36 39
Possibly/probably related AE (Day 30 to 181) 0 0 0
Serious AEs (Day 30 to 181) 1 2 0
AE's leading to discontinuation (Day 30 to 181) 0 0 0
Possibly/probably related SAE (Day 30 to 181) 0 0 0
Death (Day 30 to 181) 0 0 0
Time Frame All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
Adverse Event Reporting Description There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
 
Arm/Group Title Tdap + MenACWY-CRM Tdap + Saline MenACWY-CRM + Saline
Hide Arm/Group Description Subjects received Tdap and MenACWY-CRM vaccines concomitantly, in separate arms Subjects received Tdap vaccine and saline (placebo)concomitantly, in separate arms Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
All-Cause Mortality
Tdap + MenACWY-CRM Tdap + Saline MenACWY-CRM + Saline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tdap + MenACWY-CRM Tdap + Saline MenACWY-CRM + Saline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/359 (0.28%)   2/353 (0.57%)   0/357 (0.00%) 
Gastrointestinal disorders       
Abdominal pain upper *  0/359 (0.00%)  1/353 (0.28%)  0/357 (0.00%) 
Injury, poisoning and procedural complications       
Heat stroke *  1/359 (0.28%)  0/353 (0.00%)  0/357 (0.00%) 
Renal and urinary disorders       
Nephrolithiasis *  0/359 (0.00%)  1/353 (0.28%)  0/357 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tdap + MenACWY-CRM Tdap + Saline MenACWY-CRM + Saline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   297/359 (82.73%)   309/353 (87.54%)   238/357 (66.67%) 
Gastrointestinal disorders       
Nausea   44/359 (12.26%)  38/353 (10.76%)  31/357 (8.68%) 
General disorders       
Chills   39/359 (10.86%)  41/353 (11.61%)  47/357 (13.17%) 
Injection site erythema   119/359 (33.15%)  110/353 (31.16%)  83/357 (23.25%) 
Injection site induration   125/359 (34.82%)  131/353 (37.11%)  72/357 (20.17%) 
Injection site pain   259/359 (72.14%)  262/353 (74.22%)  139/357 (38.94%) 
Malaise   67/359 (18.66%)  57/353 (16.15%)  43/357 (12.04%) 
Pyrexia   21/359 (5.85%)  14/353 (3.97%)  21/357 (5.88%) 
Musculoskeletal and connective tissue disorders       
Arthralgia   57/359 (15.88%)  60/353 (17.00%)  40/357 (11.20%) 
Myalgia   119/359 (33.15%)  128/353 (36.26%)  80/357 (22.41%) 
Nervous system disorders       
Headache   131/359 (36.49%)  113/353 (32.01%)  136/357 (38.10%) 
Indicates events were collected by systematic assessment
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 and Diagnostics
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00329901     History of Changes
Other Study ID Numbers: V59P11
2005-005519-12 ( EudraCT Number )
First Submitted: May 23, 2006
First Posted: May 25, 2006
Results First Submitted: August 27, 2013
Results First Posted: June 18, 2014
Last Update Posted: June 18, 2014