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Trial record 1 of 1 for:    MTA21
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Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine

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ClinicalTrials.gov Identifier: NCT00777257
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : December 31, 2009
Last Update Posted : February 14, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Meningitis
Meningococcemia
Pertussis
Tetanus
Diphtheria
Interventions Biological: T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.
Biological: Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap
Enrollment 1345
Recruitment Details Study participants were enrolled from 26 April 2005 through 24 June 2005 in 21 Medical centers in the US
Pre-assignment Details A total of 1345 participants that met the inclusion and exclusion criteria were randomized and vaccinated.
Arm/Group Title Tdap + Placebo Vaccines Day 0 Tdap + Menactra® Vaccines Day 0 Menactra® + Placebo Vaccines Day 0
Hide Arm/Group Description Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
Period Title: Overall Study
Started 444 450 451
Completed 433 438 442
Not Completed 11 12 9
Reason Not Completed
Adverse Event             3             1             0
Lost to Follow-up             3             3             2
Protocol Violation             2             2             2
Withdrawal by Subject             3             6             5
Arm/Group Title Tdap + Placebo Vaccines Day 0 Tdap + Menactra® Vaccines Day 0 Menactra® + Placebo Vaccines Day 0 Total
Hide Arm/Group Description Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later. Total of all reporting groups
Overall Number of Baseline Participants 444 450 451 1345
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 444 participants 450 participants 451 participants 1345 participants
<=18 years
444
 100.0%
450
 100.0%
451
 100.0%
1345.0
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0.0
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0.0
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 444 participants 450 participants 451 participants 1345 participants
13.0  (1.87) 13.0  (1.93) 13.3  (2.05) 13.1  (1.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 444 participants 450 participants 451 participants 1345 participants
Female
220
  49.5%
193
  42.9%
186
  41.2%
599.0
Male
224
  50.5%
257
  57.1%
265
  58.8%
746.0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 444 participants 450 participants 451 participants 1345 participants
444 450 451 1345
1.Primary Outcome
Title Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine.
Hide Description [Not Specified]
Time Frame Day 0 to Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Serum bactericidal activity using baby rabbit complement (SBA-BR) titers for each meningococcal serogroup was evaluated in the per-protocol population
Arm/Group Title Tdap + Placebo Vaccines Day 0 Tdap + Menactra® Vaccines Day 0 Menactra® + Placebo Vaccines Day 0
Hide Arm/Group Description:
Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
Overall Number of Participants Analyzed 376 382 382
Measure Type: Number
Unit of Measure: Percentage of participants
Meningococcal Serogroup A 92 94 93
Meningococcal Serogroup C 80 84 87
Meningococcal Serogroup Y 79 87 87
Meningococcal Serogroup W-135 94 96 96
2.Primary Outcome
Title Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
Hide Description [Not Specified]
Time Frame Day 0 and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean concentration for each vaccine antigen was evaluated in the per-protocol population.
Arm/Group Title Tdap + Placebo Vaccines Day 0 Tdap + Menactra® Vaccines Day 0 Menactra® + Placebo Vaccines Day 0
Hide Arm/Group Description:
Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
Overall Number of Participants Analyzed 377 384 383
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Diphtheria toxoid - Day 0
0.2
(0.2 to 0.3)
0.3
(0.3 to 0.3)
56.2
(48.9 to 64.6)
Diphtheria toxoid - Day 28
7.9
(7.0 to 8.8)
49.8
(43.8 to 56.7)
38.2
(33.3 to 43.9)
Tetanus toxoid - Day 0
0.9
(0.8 to 0.9)
0.8
(0.8 to 0.9)
1.0
(0.9 to 1.1)
Tetanus toxoid - Day 28
22.8
(21.0 to 24.7)
16.4
(15.2 to 17.5)
21.1
(19.6 to 22.7)
3.Primary Outcome
Title Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
Hide Description [Not Specified]
Time Frame Day 0 and Day 28 Post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean concentration for each vaccine antigen was evaluated in the per-protocol population.
Arm/Group Title Tdap + Placebo Vaccines Day 0 Tdap + Menactra® Vaccines Day 0 Menactra® + Placebo Vaccines Day 0
Hide Arm/Group Description:
Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
Overall Number of Participants Analyzed 377 384 383
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
Pertussis Toxoid - Day 0
15.3
(13.3 to 17.5)
14.0
(12.2 to 16.0)
20.7
(18.0 to 23.9)
Pertussis Toxoid - Day 28
88.0
(79.8 to 97.1)
73.4
(67.0 to 80.3)
107.4
(97.6 to 118.2)
Filamentous Haemagglutinin - Day 0
21.4
(18.9 to 24.3)
20.0
(17.9 to 22.3)
28.5
(25.4 to 31.9)
Filamentous Haemagglutinin - Day 28
179.5
(163.2 to 197.6)
140.2
(128.0 to 153.6)
245.1
(226.4 to 265.2)
Pertactin - Day 0
9.0
(7.9 to 10.3)
8.4
(7.4 to 9.5)
11.9
(10.4 to 13.6)
Pertactin - Day 28
176.5
(156.6 to 199.0)
130.3
(116.5 to 145.9)
213.6
(192.8 to 236.6)
Fimbriae Types 2 and 3 - Day 0
13.8
(12.0 to 15.9)
12.7
(11.1 to 14.6)
14.2
(12.2 to 16.6)
Fimbriae Types 2 and 3 - Day 28
1133.4
(979.3 to 1311.7)
699.1
(602.9 to 810.7)
832.3
(712.0 to 972.8)
4.Secondary Outcome
Title Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Hide Description Solicited injection sites reactions: Erythema, swelling, and pain. Solicited systemic reactions: Fever (temperature), headache, malaise, and myalgia.
Time Frame 0 to 7 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated participants intend-to-treat population
Arm/Group Title Tdap + Placebo Vaccines Day 0 Tdap + Menactra® Vaccines Day 0 Menactra® + Placebo Vaccines Day 0
Hide Arm/Group Description:
Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
Overall Number of Participants Analyzed 444 450 451
Measure Type: Number
Unit of Measure: Percentage of participants
Any Solicited Injection Site Reaction-Tdap, Dose 1 87 84 0
Grade 3 Solicited Inj. Site Reaction-Tdap, Dose 1 10 9 0
Any Erythyma (Dose 1) 25 30 0
Grade 3 Erythema (≥ 2 inches, Dose 1) 4 3 0
Any swelling (Dose 1) 26 24 0
Grade 3 swelling (≥ 2 inches, Dose 1) 5 5 0
Any Pain (Dose 1) 85 81 0
Grade 3 Pain (Incapacitating, Dose 1) 4 4 0
Any Solicited Inj. Site Reaction-Menactra, Dose 1 0 57 58
Grd 3 Solicited Inj Site Reaction-Menactra, Dose 1 0 4 4
Any Erythyma (Dose 1) 0 19 16
Grade 3 Erythema (≥ 2 inches, Dose 1) 0 2 2
Any swelling (Dose 1) 0 14 15
Grade 3 swelling (≥ 2 inches, Dose 1) 0 2 2
Any Pain (Dose 1) 0 52 52
Grade 3 Pain (Incapacitating, Dose 1) 0 1 1
Any Solicited Inj. Site Reaction-Placebo, Dose 1 38 0 35
Grd 3 Solicited Inj. Site Reaction-Placebo, Dose 1 1 0 1
Any Erythyma (Dose 1) 11 0 11
Grade 3 Erythema (≥ 2 inches, Dose 1) 1 0 0
Any swelling (Dose 1) 11 0 9
Grade 3 swelling (≥ 2 inches, Dose 1) 1 0 0
Any Pain (Dose 1) 33 0 30
Grade 3 Pain (Incapacitating, Dose 1) 0 0 1
Any Solicited Injection Site Reaction (Dose 2) 56 24 68
Grade 3 Solicited Inj. Site Reaction (Dose 2) 4 8 6
Any Erythyma (Dose 2) 13 8 14
Grade 3 Erythema (≥ 2 inches, Dose 2) 2 1 1
Any swelling (Dose 2) 11 6 14
Grade 3 swelling (≥ 2 inches, Dose 2) 2 0 1
Any Pain (Dose 2) 51 20 65
Grade 3 Pain (Incapacitating, Dose 2) 2 1 5
Any Solicited Systemic Reaction (Dose 1) 74 69 61
Grade 3 Solicited Systemic Reaction (Dose 1) 5 7 3
Any Fever (Dose 1) 2 4 2
Grade 3 Fever (≥ 40.0 °C, Dose 1) 0 0 0
Any Headache (Dose 1) 37 38 37
Grd 3 Headache (prevents daily activities, Dose 1) 2 4 1
Any Malaise (Dose 1) 30 30 25
Grd 3 Malaise (prevents daily activities, Dose 1) 3 4 1
Any Myalgia (Dose 1) 60 54 41
Grd 3 Myalgia (prevents daily activities, Dose 1) 2 2 2
Any Solicited Systemic Reaction (Dose 2) 48 33 54
Grade 3 Solicited Systemic Reaction (Dose 2) 4 3 6
Any Fever (Dose 2) 1 1 1
Grade 3 Fever (≥ 40.0 °C, Dose 2) 0 0 0
Any Headache (Dose 2) 27 22 26
Grd 3 Headache (prevents daily activities, Dose 2) 3 2 3
Any Malaise (Dose 2) 19 13 20
Grd 3 Malaise (prevents daily activities, Dose 2) 3 1 3
Any Myalgia (Dose 2) 29 15 44
Grd 3 Myalgia (prevents daily activities, Dose 2) 1 1 3
Time Frame Adverse event data were collected over 2 months post-dose 1 vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tdap + Placebo Vaccines Day 0 Tdap + Menactra® Vaccines Day 0 Menactra® + Placebo Vaccines Day 0
Hide Arm/Group Description Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
All-Cause Mortality
Tdap + Placebo Vaccines Day 0 Tdap + Menactra® Vaccines Day 0 Menactra® + Placebo Vaccines Day 0
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tdap + Placebo Vaccines Day 0 Tdap + Menactra® Vaccines Day 0 Menactra® + Placebo Vaccines Day 0
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/444 (0.45%)      1/450 (0.22%)      1/451 (0.22%)    
Infections and infestations       
Appendicitis * 1  1/444 (0.23%)  1 0/450 (0.00%)  0 0/451 (0.00%)  0
Nervous system disorders       
Convulsion * 2  1/444 (0.23%)  1 1/450 (0.22%)  1 1/451 (0.22%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 7.1
2
Term from vocabulary, MedDRA (7.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tdap + Placebo Vaccines Day 0 Tdap + Menactra® Vaccines Day 0 Menactra® + Placebo Vaccines Day 0
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/444 (0.00%)      0/450 (0.00%)      0/451 (0.00%)    
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 ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00777257     History of Changes
Other Study ID Numbers: MTA21
First Submitted: October 21, 2008
First Posted: October 22, 2008
Results First Submitted: September 24, 2009
Results First Posted: December 31, 2009
Last Update Posted: February 14, 2014