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History of Changes for Study: NCT01430611
Study of Sanofi Pasteur and Lanzhou Institute's Meningococcal (Group A and C) Polysaccharide Vaccine in Children
Latest version (submitted April 9, 2014) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 6, 2011 None (earliest Version on record)
2 September 16, 2011 Recruitment Status, Study Status, Contacts/Locations and Study Design
3 March 27, 2012 Study Status
4 March 28, 2013 Recruitment Status, Study Status, Contacts/Locations, Eligibility, Outcome Measures and Study Identification
5 January 20, 2014 Sponsor/Collaborators, Study Status and References
6 April 9, 2014 Outcome Measures, Study Status and Results
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Study NCT01430611
Submitted Date:  September 6, 2011 (v1)

Open or close this module Study Identification
Unique Protocol ID: MPS01
Brief Title: Study of Sanofi Pasteur and Lanzhou Institute's Meningococcal (Group A and C) Polysaccharide Vaccine in Children
Official Title: 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
Secondary IDs: U1111-1120-1190 [WHO]
Open or close this module Study Status
Record Verification: September 2011
Overall Status: Recruiting
Study Start: August 2011
Primary Completion: August 2012 [Anticipated]
Study Completion: August 2012 [Anticipated]
First Submitted: September 6, 2011
First Submitted that
Met QC Criteria:
September 6, 2011
First Posted: September 8, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 6, 2011
Last Update Posted: September 8, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Sanofi
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Meningococcal Disease
Meningitis
Keywords: Meningitis
Neisseria meningitidis
Meningo A+C®
Meng Ling Kang®
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 4
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Outcomes Assessor)
Allocation: Randomized
Enrollment: 666 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine Biological: Meningococcal (Groups A and C) Polysaccharide Vaccine
0.5 mL, Subcutaneous
Other Names:
  • Meningo A+C®
Active Comparator: Lanzhou Institute Meningococcal A+C Polysaccharide Vaccine Biological: Meningococcal (Groups A and C) Polysaccharide Vaccine
0.5 mL, Subcutaneous
Other Names:
  • Meng Ling Kang®
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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)
Secondary Outcome Measures:
1. 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
Open or close this module Eligibility
Minimum Age: 2 Years
Maximum Age: 6 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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 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.
Open or close this module Contacts/Locations
Central Contact Person: Public Registry Sanofi Pasteur
Email: RegistryContactUs@sanofipasteur.com
Study Officials: Medical Director
Study Director
Sanofi Pasteur SA
Locations: China, Jiangstu Province
[Recruiting]
Chuzhou, Jiangstu Province, China, 223200
[Recruiting]
Nanjing, Jiangstu Province, China, 210009
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: Related Info
Available IPD/Information:

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