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

Sanofi

Status and phase

Completed

Phase 4

Conditions

Meningitis

Meningococcal Disease

Treatments

Biological: Meningococcal (Groups A and C) Polysaccharide Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01430611

U1111-1120-1190 (Other Identifier)

MPS01

Details and patient eligibility

About

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.

Full 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.

Enrollment

666 patients

Sex

All

Ages

2 to 6 years old

Volunteers

Accepts Healthy Volunteers

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.