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Study of Sanofi Pasteur and Lanzhou Institute's Meningococcal (Group A and C) Polysaccharide Vaccine in Children

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ClinicalTrials.gov Identifier: NCT01430611
Recruitment Status : Completed
First Posted : September 8, 2011
Results First Posted : May 8, 2014
Last Update Posted : May 8, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Meningococcal Disease
Meningitis
Intervention: Biological: Meningococcal (Groups A and C) Polysaccharide Vaccine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study participants were enrolled from 23 August 2011 to 12 October 2011 at a single center in China.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 665 of the 666 participants who met all of the inclusion and none of the exclusion criteria that were randomized were vaccinated in this study.

Reporting Groups
  Description
Meningo A+C® (Group 1) Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
Meng Ling Kang® (Group 2) Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine

Participant Flow:   Overall Study
    Meningo A+C® (Group 1)   Meng Ling Kang® (Group 2)
STARTED   332   333 
COMPLETED   315   318 
NOT COMPLETED   17   15 
Adverse Event                0                1 
Protocol Violation                1                0 
Lost to Follow-up                1                0 
Withdrawal by Subject                15                14 



  Baseline Characteristics

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
Meningo A+C® (Group 1) Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
Meng Ling Kang® (Group 2) Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Total Total of all reporting groups

Baseline Measures
   Meningo A+C® (Group 1)   Meng Ling Kang® (Group 2)   Total 
Overall Participants Analyzed 
[Units: Participants]
 332   333   665 
Age 
[Units: Participants]
     
<=18 years   332   333   665 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 3.2  (1.1)   3.1  (1.0)   3.2  (1.1) 
Gender 
[Units: Participants]
     
Female   144   133   277 
Male   188   200   388 
Region of Enrollment 
[Units: Participants]
     
China   332   333   665 


  Outcome Measures

1.  Primary:   Number of Participants With Seroconversion Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine   [ Time Frame: Day 30 post-vaccination ]

2.  Secondary:   Percentage of Participants With Post-vaccination Titer ≥1:8 for Serogroup A Before and Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine   [ Time Frame: Day 0 (pre-vaccination) and Day 30 post-vaccination ]

3.  Secondary:   Percentage of Participants With Post-vaccination Titer ≥1:8 for Serogroup C Before and Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine   [ Time Frame: Day 0 (pre-vaccination) and Day 30 post-vaccination ]

4.  Secondary:   Geometric Mean Titers of Serogroup A and C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine   [ Time Frame: Day 0 (pre-vaccination) and Day 30 post-vaccination ]

5.  Secondary:   Geometric Mean Titers of Serogroup A Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine   [ Time Frame: Day 0 (pre-vaccination) and Day 30 post-vaccination ]

6.  Secondary:   Geometric Mean Titers of Serogroup C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine   [ Time Frame: Day 0 (pre-vaccination) and Day 30 post-vaccination ]

7.  Secondary:   Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine   [ Time Frame: Day 0 up to Day 7 post-vaccination ]


  Serious Adverse Events


  Other Adverse Events


  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.


  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.


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



Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01430611     History of Changes
Other Study ID Numbers: MPS01
U1111-1120-1190 ( Other Identifier: WHO )
First Submitted: September 6, 2011
First Posted: September 8, 2011
Results First Submitted: February 28, 2014
Results First Posted: May 8, 2014
Last Update Posted: May 8, 2014