Full Text View
Tabular View
Study Results
Related Studies
Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®
This study has been completed.
Study NCT00355121   Information provided by Sanofi-Aventis

First Received on July 20, 2006.   Last Updated on August 22, 2011   History of Changes
Results First Received: July 25, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Meningococcal Meningitis
Tetanus
Diphtheria
Pertussis
Poliomyelitis
Intervention: Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled from 16 October 2006 to 21 June 2007 in 45 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 881 participants who met the inclusion and exclusion criteria were enrolled. Data on 879 that were vaccinated are presented in this reported.

Reporting Groups
  Description
Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 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
Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 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
Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 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

Participant Flow:   Overall Study
    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  
STARTED     353     353     175  
COMPLETED     332     324     170  
NOT COMPLETED     21     29     5  
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  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 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
Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 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
Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 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

Baseline Measures
    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  
Number of Participants  
[units: participants]
  353     353     175     881  
Age  
[units: participants]
       
<=18 years     353     353     175     881  
Between 18 and 65 years     0     0     0     0  
>=65 years     0     0     0     0  
Age  
[units: Years]
Mean ± Standard Deviation
  4.5  ± 0.48     4.5  ± 0.51     4.5  ± 0.49     4.5  ± 0.50  
Gender  
[units: participants]
       
Female     172     182     73     427  
Male     181     171     102     454  
Region of Enrollment  
[units: participants]
       
United States     353     353     175     881  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination   [ Time Frame: Day 30 post-vaccination (Visit 1) ]

2.  Primary:   Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.   [ Time Frame: Day 30 post-vaccination (Visit 1) ]

3.  Secondary:   Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1   [ Time Frame: Day 30 post-vaccination 1 ]

4.  Secondary:   Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination   [ Time Frame: Day 30 post-vaccination ]

5.  Secondary:   Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine   [ Time Frame: Day 0 through Day 7 post-vaccination at Visit 1 ]

6.  Other Pre-specified:   Geometric Mean Titers Against Poliovirus After IPOL Vaccination.   [ Time Frame: Day 30 post-vaccination ]

7.  Other Pre-specified:   Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1   [ Time Frame: Day 0 through Day 7 post-vaccination ]

8.  Other Pre-specified:   Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2   [ Time Frame: Day 0 through Day 7 post-vaccination ]


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00355121     History of Changes
Other Study ID Numbers: MTA43
Study First Received: July 20, 2006
Results First Received: July 25, 2011
Last Updated: August 22, 2011
Health Authority: United States: Food and Drug Administration