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

NCT01430611 | Completed Phase 4 Results

• 2 other identifiers: MPS01U1111-1120-1190
• Study Type: interventional
• Target: 666
• Locations: 1 country
• Sites: 2

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.

Conditions

Meningococcal Disease; Meningitis

Keywords

Meningitis; Neisseria meningitidis; Meningo A+C®; Meng Ling Kang®

Outcome Measures

Primary Outcomes (1)

• 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

  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).

  Day 30 post-vaccination

Secondary Outcomes (6)

• 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

  Day 0 (pre-vaccination) and Day 30 post-vaccination

• 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

  Day 0 (pre-vaccination) and Day 30 post-vaccination

• 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

  Day 0 (pre-vaccination) and Day 30 post-vaccination

• 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

  Day 0 (pre-vaccination) and Day 30 post-vaccination

• 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

  Day 0 (pre-vaccination) and Day 30 post-vaccination

Study Arms (2)

Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine

EXPERIMENTAL

Biological: Meningococcal (Groups A and C) Polysaccharide Vaccine

Lanzhou Institute Meningococcal A+C Polysaccharide Vaccine

ACTIVE COMPARATOR

Biological: Meningococcal (Groups A and C) Polysaccharide Vaccine

Interventions

Meningococcal (Groups A and C) Polysaccharide Vaccine BIOLOGICAL

0.5 mL, Subcutaneous

Also known as: Meningo A+C®

Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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:
• persons with increased susceptibility such as persistent complement component deficiencies,
• persons with anatomic or functional asplenia,
• 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
• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (2)

Unknown Facility

Chuzhou, 223200, China

Location

Unknown Facility

Nanjing, 210009, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Meningococcal Infections; Meningitis

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neuroinflammatory Diseases; Nervous System Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur SA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2011
• First Posted: September 8, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: November 1, 2012
• Last Updated: May 8, 2014
• Results First Posted: May 8, 2014

Record last verified: 2014-04

Locations

CN (2)