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

• 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: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information

• First Submitted Date: September 6, 2011
• First Posted Date: September 8, 2011
• Results First Submitted Date: February 28, 2014
• Results First Posted Date: May 8, 2014
• Last Update Posted Date: May 8, 2014
• Study Start Date: August 2011
• Actual Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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)

Current Secondary Outcome Measures (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 (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: 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

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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention

Condition

• Meningococcal Disease
• Meningitis

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 6, 2011): 666
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 2012
• Actual Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Eligibility 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 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

• Sexes Eligible for Study: All

• Ages: 2 Years to 6 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01430611
• Other Study ID Numbers: MPS01; U1111-1120-1190 ( Other Identifier: WHO )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
• Original Responsible Party: Sanofi
• Current Study Sponsor: Sanofi Pasteur, a Sanofi Company
• Original Study Sponsor: Sanofi
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; Sanofi Pasteur SA

• PRS Account: Sanofi
• Verification Date: April 2014