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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 )

Tracking Information
First Submitted Date  ICMJE September 6, 2011
First Posted Date  ICMJE September 8, 2011
Results First Submitted Date  ICMJE February 28, 2014
Results First Posted Date  ICMJE May 8, 2014
Last Update Posted Date May 8, 2014
Study Start Date  ICMJE August 2011
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2014)
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 ]
Seroconversion status was defined as antibody titers against meningococcal serogroups A and C, 30 days after vaccine administration ≥ 4-fold increase from pre-vaccination level measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2011)
Seroconversion status defined as antibody titers against meningococcal serogroups A and C 30 days after vaccine administration ≥ 4 fold increase from pre vaccination level [ Time Frame: 30 Days post-vaccination ]
Immunogenicity status will be measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (TTC SBA-BR)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2014)
  • 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 ]
    Meningococcal Group A antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR)..
  • 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 ]
    Meningococcal Group C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR)..
  • 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 ]
    Meningococcal Group A and C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).
  • 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 ]
    Meningococcal Group A antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).
  • 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 ]
    Meningococcal Group C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).
  • 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 ]
    Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection site: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥30 mm. Grade 3 systemic reactions: Fever, temperature >39˚C; Headache, Malaise, and Myalgia, Significant, preventing daily activity.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2011)
Information concerning the safety in terms of solicited injection site and systemic reactions following vaccination, and unsolicited adverse events and serious adverse events throughout the trial period [ Time Frame: Day 0 up to 30 Days post-vaccination ]
Solicited injection site reactions: Pain, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Sanofi Pasteur and Lanzhou Institute's Meningococcal (Group A and C) Polysaccharide Vaccine in Children
Official Title  ICMJE Safety and Immunogenicity of Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide Vaccine Versus Lanzhou Institute for Biological Products Meningococcal (Groups A and C) Polysaccharide Vaccine in Children 2-6 Years of Age in China
Brief Summary

This study is part of the post-licensure commitment to evaluate the safety and immunogenicity of Meningo A+C vaccine in healthy Chinese children 2 to 6 years of age.

Primary Objective:

To demonstrate the non-inferiority in terms of seroconversion rate for serogroups A and C, 30 days after a single dose of Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide Vaccine versus Lanzhou Institute for Biological Products Meningococcal (Groups A and C) Polysaccharide Vaccine.

Secondary Objective:

  • To describe the immunogenicity for serogroups A and C, 30 days after administration of the study vaccines given as a single dose.
  • To describe the full reactogenicity profile after administration of the study vaccines given as a single dose.
Detailed Description Eligible participants will receive one injection of either Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide Vaccine or Lanzhou Institute for Biological Products Meningococcal (Groups A and C) Polysaccharide Vaccine and will be monitored for safety and immunogenicity for up to 30 days post-vaccination.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Meningococcal Disease
  • Meningitis
Intervention  ICMJE
  • Biological: Meningococcal (Groups A and C) Polysaccharide Vaccine
    0.5 mL, Subcutaneous
    Other Name: Meningo A+C®
  • Biological: Meningococcal (Groups A and C) Polysaccharide Vaccine
    0.5 mL, Subcutaneous
    Other Name: Meng Ling Kang®
Study Arms  ICMJE
  • Experimental: Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
    Intervention: Biological: Meningococcal (Groups A and C) Polysaccharide Vaccine
  • Active Comparator: Lanzhou Institute Meningococcal A+C Polysaccharide Vaccine
    Intervention: Biological: Meningococcal (Groups A and C) Polysaccharide Vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 6, 2011)
666
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 2 to 6 years on the day of inclusion
  • Informed consent form has been signed and dated by the parent or another legally acceptable representative
  • Subject and parent/ legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
  • Written documentation of immunization history against meningococcal disease according to the national Expanded Program on Immunization (EPI) schedule (including 2 doses with Meningococcal Group A Polysaccharide Vaccine between 6 and 18 months of age).

Exclusion Criteria:

  • Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination (except for influenza vaccination, which may be received at least 2 weeks before study vaccines)
  • Previous vaccination against meningococcal disease within the past 12 months with either the trial vaccine or another vaccine
  • Previous vaccination with any meningococcal conjugate vaccine.
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
  • At high risk for meningococcal disease during the trial, including:

    1. persons with increased susceptibility such as persistent complement component deficiencies,
    2. persons with anatomic or functional asplenia,
    3. persons who have exposure (e.g., microbiologists routinely working with N. meningitidis, or travelers to or residents of areas where meningococcal disease is hyperendemic or epidemic)
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
  • Known thrombocytopenia, as reported by the parent/ legally acceptable representative, contraindicating intramuscular vaccination
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
  • Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature ≥ 37.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
  • Receipt of oral or injected antibiotic therapy within 72 hours before the first blood draw
  • Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
  • Any contraindication as listed in the study vaccines leaflets.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01430611
Other Study ID Numbers  ICMJE MPS01
U1111-1120-1190 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Original Responsible Party Sanofi
Current Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Original Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur SA
PRS Account Sanofi
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP