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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01430611
First received: September 6, 2011
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.

Condition Intervention Phase
Meningococcal Disease
Meningitis
Biological: Meningococcal (Groups A and C) Polysaccharide Vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 666
Study Start Date: August 2011
Study Completion Date: November 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine Biological: Meningococcal (Groups A and C) Polysaccharide Vaccine
0.5 mL, Subcutaneous
Other Name: 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 Name: Meng Ling Kang®

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.

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430611

Locations
China
Chuzhou, China, 223200
Nanjing, China, 210009
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur SA
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01430611     History of Changes
Other Study ID Numbers: MPS01, U1111-1120-1190
Study First Received: September 6, 2011
Results First Received: February 28, 2014
Last Updated: April 9, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Sanofi:
Meningitis
Neisseria meningitidis
Meningo A+C®
Meng Ling Kang®

Additional relevant MeSH terms:
Meningitis
Meningococcal Infections
Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Nervous System Diseases

ClinicalTrials.gov processed this record on October 20, 2014