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Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00777257
First received: October 21, 2008
Last updated: December 1, 2009
Last verified: December 2009
History of Changes
Results First Received: September 24, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study participants were enrolled from 26 April 2005 through 24 June 2005 in 21 Medical centers in the US

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 1345 participants that met the inclusion and exclusion criteria were randomized and vaccinated.

Reporting Groups
  Description
Tdap + Placebo Vaccines Day 0 Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
Tdap + Menactra® Vaccines Day 0 Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
Menactra® + Placebo Vaccines Day 0 Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.

Participant Flow:   Overall Study
    Tdap + Placebo Vaccines Day 0     Tdap + Menactra® Vaccines Day 0     Menactra® + Placebo Vaccines Day 0  
STARTED     444     450     451  
COMPLETED     433     438     442  
NOT COMPLETED     11     12     9  
Adverse Event                 3                 1                 0  
Lost to Follow-up                 3                 3                 2  
Protocol Violation                 2                 2                 2  
Withdrawal by Subject                 3                 6                 5  



  Baseline Characteristics
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Reporting Groups
  Description
Tdap + Placebo Vaccines Day 0 Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
Tdap + Menactra® Vaccines Day 0 Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
Menactra® + Placebo Vaccines Day 0 Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
Total Total of all reporting groups

Baseline Measures
    Tdap + Placebo Vaccines Day 0     Tdap + Menactra® Vaccines Day 0     Menactra® + Placebo Vaccines Day 0     Total  
Number of Participants  
[units: participants]
 		  444     450     451     1345  
Age  
[units: participants]
 		       
<=18 years     444     450     451     1345  
Between 18 and 65 years     0     0     0     0  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  13.0  ± 1.87     13.0  ± 1.93     13.3  ± 2.05     13.1  ± 1.95  
Gender  
[units: participants]
 		       
Female     220     193     186     599  
Male     224     257     265     746  
Region of Enrollment  
[units: participants]
 		       
United States     444     450     451     1345  



  Outcome Measures
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1.  Primary:   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.   [ Time Frame: Day 0 to Day 28 post-vaccination ]
  Show Outcome Measure 1

2.  Primary:   Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.   [ Time Frame: Day 0 and Day 28 post-vaccination ]
  Show Outcome Measure 2

3.  Primary:   Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.   [ Time Frame: Day 0 and Day 28 Post-vaccination ]
  Show Outcome Measure 3

4.  Secondary:   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.   [ Time Frame: 0 to 7 days post-vaccination ]
  Hide Outcome Measure 4

Measure Type Secondary
Measure 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.
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis was on all enrolled and vaccinated participants intend-to-treat population

Reporting Groups
  Description
Tdap + Placebo Vaccines Day 0 Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
Tdap + Menactra® Vaccines Day 0 Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
Menactra® + Placebo Vaccines Day 0 Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.

Measured Values
    Tdap + Placebo Vaccines Day 0     Tdap + Menactra® Vaccines Day 0     Menactra® + Placebo Vaccines Day 0  
Number of Participants Analyzed  
[units: participants]
 		  444     450     451  
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.  
[units: 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  

No statistical analysis provided for 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.




  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
e-mail: RegistryContactUs@sanofipasteur.com


No publications provided


Responsible Party: Medical Monitor, Sanofi Pasteur Inc.
ClinicalTrials.gov Identifier: NCT00777257     History of Changes
Other Study ID Numbers: MTA21
Study First Received: October 21, 2008
Results First Received: September 24, 2009
Last Updated: December 1, 2009
Health Authority: United States: Food and Drug Administration