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

Meningitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01430611
• Other study ID #: MPS01
• Secondary ID: U1111-1120-1190
• Status: Completed
• Phase: Phase 4
• First received: September 6, 2011
• Last updated: April 9, 2014
• Start date: August 2011
• Est. completion date: November 2012

Study information

• Verified date: April 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 666
• Est. completion date: November 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 6 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Meningitis
• Meningococcal Disease
• Meningococcal Infections

Intervention

Biological:
• Meningococcal (Groups A and C) Polysaccharide Vaccine
0.5 mL, Subcutaneous
• Meningococcal (Groups A and C) Polysaccharide Vaccine
0.5 mL, Subcutaneous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Meningococcal Group A antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR)..	Day 0 (pre-vaccination) and Day 30 post-vaccination	No
Secondary	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	Meningococcal Group C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR)..	Day 0 (pre-vaccination) and Day 30 post-vaccination	No
Secondary	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	Meningococcal Group A and C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).	Day 0 (pre-vaccination) and Day 30 post-vaccination	No
Secondary	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	Meningococcal Group A antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).	Day 0 (pre-vaccination) and Day 30 post-vaccination	No
Secondary	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	Meningococcal Group C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).	Day 0 (pre-vaccination) and Day 30 post-vaccination	No
Secondary	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	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.	Day 0 up to Day 7 post-vaccination	No

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