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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

666 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Meningococcal Disease Meningitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine

Group Type EXPERIMENTAL

Meningococcal (Groups A and C) Polysaccharide Vaccine

Intervention Type BIOLOGICAL

0.5 mL, Subcutaneous

Lanzhou Institute Meningococcal A+C Polysaccharide Vaccine

Group Type ACTIVE_COMPARATOR

Meningococcal (Groups A and C) Polysaccharide Vaccine

Intervention Type BIOLOGICAL

0.5 mL, Subcutaneous

Interventions

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Meningococcal (Groups A and C) Polysaccharide Vaccine

0.5 mL, Subcutaneous

Intervention Type BIOLOGICAL

Meningococcal (Groups A and C) Polysaccharide Vaccine

0.5 mL, Subcutaneous

Intervention Type BIOLOGICAL

Other Intervention Names

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Meningo A+C® Meng Ling Kang®

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes