Study of a Single Dose of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) in Japanese Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01519713
First received: January 20, 2012
Last updated: May 22, 2013
Last verified: May 2013
Results First Received: April 4, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Meningitis
Meningococcal Meningitis
Meningococcal Infections
Intervention: Biological: Meningococcal polysaccharide diphtheria toxoid conjugate

  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 20 January through 25 February 2012 in 4 clinic sites in Japan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 200 subjects who met the inclusion, but no exclusion criteria were enrolled and vaccinated.

Reporting Groups
  Description
Adults Menactra® Vaccine Group Participants aged 18 to 55 years received a single dose of Menactra® vaccine
Adolescents Menactra® Vaccine Group Participants aged 11 to 17 years received a single dose of Menactra® vaccine
Children Menactra® Vaccine Group Participants aged 2 to 10 years received a single dose of Menactra® vaccine

Participant Flow:   Overall Study
    Adults Menactra® Vaccine Group     Adolescents Menactra® Vaccine Group     Children Menactra® Vaccine Group  
STARTED     194     2     4  
COMPLETED     194     2     4  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Adults Menactra® Vaccine Group Participants aged 18 to 55 years received a single dose of Menactra® vaccine
Adolescents Menactra® Vaccine Group Participants aged 11 to 17 years received a single dose of Menactra® vaccine
Children Menactra® Vaccine Group Participants aged 2 to 10 years received a single dose of Menactra® vaccine
Total Total of all reporting groups

Baseline Measures
    Adults Menactra® Vaccine Group     Adolescents Menactra® Vaccine Group     Children Menactra® Vaccine Group     Total  
Number of Participants  
[units: participants]
  194     2     4     200  
Age  
[units: participants]
       
<=18 years     0     2     4     6  
Between 18 and 65 years     194     0     0     194  
>=65 years     0     0     0     0  
Age  
[units: Years]
Mean ± Standard Deviation
  35.6  ± 11.2     11.0  ± 0.0     4.3  ± 2.6     34.7  ± 12.1  
Gender  
[units: participants]
       
Female     97     0     2     99  
Male     97     2     2     101  
Region of Enrollment  
[units: Participants]
       
Japan     194     2     4     200  



  Outcome Measures
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1.  Primary:   Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine   [ Time Frame: 28 Days post-vaccination ]

2.  Secondary:   Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine   [ Time Frame: 28 Days post-vaccination ]

3.  Secondary:   Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine.   [ Time Frame: 28 Days post-vaccination ]

4.  Secondary:   Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine   [ Time Frame: Days 0 and 28 post-vaccination ]

5.  Secondary:   Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine   [ Time Frame: 28 Days post-vaccination ]

6.  Secondary:   Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine   [ Time Frame: Day 0 up to Day 28 post-vaccination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


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


No publications provided


Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01519713     History of Changes
Other Study ID Numbers: MTA76 (SFY12080), U1111-1124-7479
Study First Received: January 20, 2012
Results First Received: April 4, 2013
Last Updated: May 22, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency