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Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®

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ClinicalTrials.gov Identifier: NCT00355121
Recruitment Status : Completed
First Posted : July 21, 2006
Results First Posted : August 23, 2011
Last Update Posted : August 24, 2011
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Meningococcal Meningitis
Tetanus
Diphtheria
Pertussis
Poliomyelitis
Intervention Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Enrollment 882
Recruitment Details Participants were enrolled from 16 October 2006 to 21 June 2007 in 45 medical centers in the US.
Pre-assignment Details A total of 881 participants who met the inclusion and exclusion criteria were enrolled. Data on 879 that were vaccinated are presented in this reported.
Arm/Group Title Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
Hide Arm/Group Description Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2 Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2 Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
Period Title: Overall Study
Started 353 353 175
Completed 332 324 170
Not Completed 21 29 5
Reason Not Completed
Did not receive study vaccine             1             0             1
Adverse Event             0             1             0
Protocol Violation             7             9             1
Lost to Follow-up             4             7             1
Withdrawal by Subject             9             10             2
Serious adverse events             0             2             0
Arm/Group Title Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 Total
Hide Arm/Group Description Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2 Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2 Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2 Total of all reporting groups
Overall Number of Baseline Participants 353 353 175 881
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 353 participants 353 participants 175 participants 881 participants
<=18 years
353
 100.0%
353
 100.0%
175
 100.0%
881
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 353 participants 353 participants 175 participants 881 participants
4.5  (0.48) 4.5  (0.51) 4.5  (0.49) 4.5  (0.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 353 participants 353 participants 175 participants 881 participants
Female
172
  48.7%
182
  51.6%
73
  41.7%
427
  48.5%
Male
181
  51.3%
171
  48.4%
102
  58.3%
454
  51.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 353 participants 353 participants 175 participants 881 participants
353 353 175 881
1.Primary Outcome
Title Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination
Hide Description Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay.
Time Frame Day 30 post-vaccination (Visit 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Serum antibody titers were assessed in the per-protocol population. (Participants in Group 3 did not receive DAPTACEL vaccine at Visit 1)
Arm/Group Title Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
Hide Arm/Group Description:
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
Overall Number of Participants Analyzed 250 238 0
Measure Type: Number
Unit of Measure: Participants
Diphtheria Antibody Concentration ≥ 1.0 IU/mL 249 238
Tetanus Antibody Concentration ≥ 1.0 IU/mL 246 236
2.Primary Outcome
Title Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.
Hide Description Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)
Time Frame Day 30 post-vaccination (Visit 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Serum antibody titers were assessed in the per-protocol population. (Participants in Group 1 did not receive Menactra vaccine at Visit 1)
Arm/Group Title Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
Hide Arm/Group Description:
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
Overall Number of Participants Analyzed 0 238 121
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serogroup A (N = 0, 131, 104)
10.8
(8.7 to 13.3)
10.4
(8.1 to 13.3)
Serogroup C (N = 0, 131, 103)
8.1
(6.3 to 10.5)
7.8
(5.8 to 10.7)
Serogroup Y (N = 0, 131, 104)
18.1
(14.2 to 22.9)
26.2
(20.0 to 34.4)
Serogroup W-135 (N = 0, 131, 104)
22.8
(18.5 to 28.1)
21.7
(16.6 to 28.4)
3.Secondary Outcome
Title Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1
Hide Description Serum antibody titers against pertussis were assessed for pertussis toxoid (PT), filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), and pertactin (RN) by enzyme linked immunosorbent assay (ELISA).
Time Frame Day 30 post-vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Serum antibody titers were assessed in the per-protocol population. (Participants in Group 3 did not receive DAPTACEL vaccine at Visit 1)
Arm/Group Title Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
Hide Arm/Group Description:
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
Overall Number of Participants Analyzed 250 238 0
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
Pertussis toxoid (PT; N = 243, 236, 0)
70.0
(63.0 to 77.8)
71.0
(63.8 to 79.0)
Filamentous hemagglutinin (FHA; N = 246, 237, 0)
133
(117 to 152)
145
(127 to 165)
Fimbriae Types 2 and 3 (FIM; N = 243, 238, 0)
123
(92.5 to 164)
113
(84.0 to 151)
Pertactin (PRN; N = 247, 238, 0)
115
(97.0 to 136)
118
(102 to 137)
4.Secondary Outcome
Title Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination
Hide Description Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)
Time Frame Day 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Serum antibody titers were assessed in the per protocol population. Participants in Group 1 received Menactra vaccine at Visit 2, Group 3 at Visit 1.
Arm/Group Title Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
Hide Arm/Group Description:
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
Overall Number of Participants Analyzed 250 0 121
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serogroup A (N = 137, 0, 104)
6.7
(5.7 to 8.0)
10.4
(8.1 to 13.3)
Serogroup C (N = 138, 0, 103)
3.3
(2.7 to 3.9)
7.8
(5.8 to 10.7)
Serogroup Y (N = 138, 0, 104)
6.5
(5.1 to 8.2)
26.2
(20.0 to 34.4)
Serogroup W-135 (N = 138, 0, 104)
8.4
(6.7 to 10.6)
21.7
(16.6 to 28.4)
5.Secondary Outcome
Title Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine
Hide Description Fever was defined as a maximum oral temperature of ≥ 100.4ºF.
Time Frame Day 0 through Day 7 post-vaccination at Visit 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on enrolled and vaccinated participants with available reaction data, intent-to-treat population.
Arm/Group Title Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
Hide Arm/Group Description:
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
Overall Number of Participants Analyzed 341 344 0
Measure Type: Number
Unit of Measure: Participants
27 18
6.Other Pre-specified Outcome
Title Geometric Mean Titers Against Poliovirus After IPOL Vaccination.
Hide Description Serum antibodies were assessed for poliovirus types 1, 2, and 3 by serum neutralization assay.
Time Frame Day 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Serum antibody titers were assessed in the per-protocol population. (Participants received IPOL at Visit 1 in Group 1 and 3, and at Visit 2 for Group 2
Arm/Group Title Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
Hide Arm/Group Description:
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
Overall Number of Participants Analyzed 250 238 121
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Type 1 (N = 243, 235, 120)
5094.8
(4427.8 to 5862.4)
5767
(4982.7 to 6674.9)
4885.1
(4013.2 to 5946.4)
Type 2 (N = 245, 237, 120)
5209.5
(4549.0 to 5966.0)
6195.6
(5325.3 to 7208.1)
5373.6
(4461.0 to 6472.8)
Type 3 (N = 245, 236, 120)
6777.5
(5766.9 to 7965.2)
7815.9
(6601.0 to 9254.5)
5843
(4523.4 to 7547.6)
7.Other Pre-specified Outcome
Title Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Hide Description Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Time Frame Day 0 through Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.
Arm/Group Title Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
Hide Arm/Group Description:
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
Overall Number of Participants Analyzed 341 344 169
Measure Type: Number
Unit of Measure: Participants
Any Injection Site Pain: DAPTACEL 236 229 NA [1] 
Grade 3 Pain (Incapacitating): DAPTACEL 2 2 NA [1] 
Any Injection Site Erythema: DAPTACEL 161 161 NA [1] 
Grade 3 Erythema (≥ 2 in): DAPTACEL 75 73 NA [1] 
Any Injection Site Swelling: DAPTACEL 113 109 NA [1] 
Grade 3 Swelling (≥ 2 in): DAPTACEL 54 41 NA [1] 
Any Injection Site Pain: Menactra NA [2]  201 93
Grade 3 Pain (Incapacitating): Menactra NA [2]  1 2
Any Injection Site Erythema: Menactra NA [2]  103 31
Grade 3 Erythema (≥ 2 in): Menactra NA [2]  16 6
Any Injection Site Swelling: Menactra NA [2]  66 21
Grade 3 Swelling (≥ 2 in): Menactra NA [2]  18 5
Any Injection Site Pain: IPOL 207 NA [3]  98
Grade 3 Pain (Incapacitating): IPOL 3 NA [3]  2
Any Injection Site Erythema: IPOL 59 NA [3]  23
Grade 3 Erythema (≥ 2 in): IPOL 10 NA [3]  2
Any Injection Site Swelling: IPOL 39 NA [3]  12
Grade 3 Swelling (≥ 2 in): IPOL 8 NA [3]  2
Any Fever 27 18 13
Grade 3 Fever (> 39.5 ºC or ≥ 103.2 ºF) 1 3 0
Any Headache 48 42 22
Grade 3 Headache (Prevents daily activities) 2 1 0
Any Malaise 86 81 44
Grade 3 Malaise (Prevents daily activities) 8 2 5
Any Myalgia 153 123 44
Grade 3 Myalgia (Prevents daily activities) 6 3 0
[1]
DAPTACEL was not administered at Visit 1
[2]
Menactra was not administered at Visit 1
[3]
IPOL was not administered at Visit 1
8.Other Pre-specified Outcome
Title Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2
Hide Description Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Time Frame Day 0 through Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
Arm/Group Title Group 1: Menactra on Day 30 (Visit 2) Group 2: IPOL on Day 30 (Visit 2) Group 3: DAPTACEL on Day 30 (Visit 2)
Hide Arm/Group Description:
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
Overall Number of Participants Analyzed 328 327 165
Measure Type: Number
Unit of Measure: Participants
Any Injection Site Pain 168 128 85
Grade 3 Pain (Incapacitating) 2 1 0
Any Injection Site Erythema 80 54 42
Grade 3 Erythema (≥ 2 inches) 24 2 18
Any Injection Site Swelling 58 31 32
Grade 3 Swelling (≥ 2 inches) 19 1 10
Any Fever 12 17 11
Grade 3 Fever (> 39.5 ºC or ≥ 103.2 ºF) 1 1 0
Any Headache 27 21 12
Grade 3 Headache (Prevents daily activities) 1 2 1
Any Malaise 46 47 37
Grade 3 Malaise (Prevents daily activities) 4 8 3
Any Myalgia 78 55 42
Grade 3 Myalgia (Prevents daily activities) 2 3 1
Time Frame Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
Hide Arm/Group Description Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2 Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2 Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
All-Cause Mortality
Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/341 (0.00%)      2/344 (0.58%)      1/169 (0.59%)    
Blood and lymphatic system disorders       
Pancytopenia * 1  0/341 (0.00%)  0 1/344 (0.29%)  1 0/169 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration * 1  0/341 (0.00%)  0 0/344 (0.00%)  0 1/169 (0.59%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Rhabdomyosarcoma * 1  0/341 (0.00%)  0 1/344 (0.29%)  1 0/169 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   236/341 (69.21%)      229/344 (66.57%)      98/169 (57.99%)    
Gastrointestinal disorders       
Vomiting * 1  14/341 (4.11%)  14 18/344 (5.23%)  18 10/169 (5.92%)  10
General disorders       
Injection Site Pain  1  236/329 (71.73%)  236 229/330 (69.39%)  229 98/166 (59.04%)  98
Injection Site Erythema  1  161/330 (48.79%)  161 161/330 (48.79%)  161 42/163 (25.77%)  42
Injection Site Swelling  1  113/330 (34.24%)  113 109/329 (33.13%)  109 32/162 (19.75%)  32
Fever  1  27/328 (8.23%)  27 18/325 (5.54%)  18 13/163 (7.98%)  13
Malaise  1  86/331 (25.98%)  86 81/330 (24.55%)  81 44/165 (26.67%)  44
Injection Site Induration * 1  22/341 (6.45%)  22 16/344 (4.65%)  16 12/169 (7.10%)  12
Injection Site Pruritus * 1  18/341 (5.28%)  18 15/344 (4.36%)  15 0/169 (0.00%)  0
Infections and infestations       
Upper Respiratory Tract Infection * 1  9/341 (2.64%)  9 12/343 (3.50%)  12 11/169 (6.51%)  11
Musculoskeletal and connective tissue disorders       
Myalgia  1  153/331 (46.22%)  153 123/330 (37.27%)  123 44/165 (26.67%)  44
Nervous system disorders       
Headache  1  48/331 (14.50%)  48 42/330 (12.73%)  42 22/165 (13.33%)  22
Respiratory, thoracic and mediastinal disorders       
Cough * 1  38/341 (11.14%)  38 39/343 (11.37%)  39 23/169 (13.61%)  23
Rhinorrhoea * 1  15/341 (4.40%)  15 22/343 (6.41%)  22 9/169 (5.33%)  9
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00355121     History of Changes
Other Study ID Numbers: MTA43
First Submitted: July 20, 2006
First Posted: July 21, 2006
Results First Submitted: July 25, 2011
Results First Posted: August 23, 2011
Last Update Posted: August 24, 2011