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

Phase 4

Completed

Conditions: Meningococcal Disease
Meningitis

Interventions: Biological: Meningococcal (Groups A and C) Polysaccharide Vaccine

Registration Number: NCT01430611

Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 666

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine	Meningococcal (Groups A and C) Polysaccharide Vaccine	-
Lanzhou Institute Meningococcal A+C Polysaccharide Vaccine	Meningococcal (Groups A and C) Polysaccharide Vaccine	-

Primary Outcome Measures

Name	Time	Method
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	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).

Secondary Outcome Measures

Name	Time	Method
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	Meningococcal Group C 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 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	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	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	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.
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	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	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).