Phase 4
Completed N=665
Study of Sanofi Pasteur and Lanzhou Institute's Meningococcal (Group A and C) Polysaccharide Vaccine in Children
Source: ClinicalTrials.gov NCT01430611 ↗Enrolled (actual)
665
Serious AEs
0.4%
Results posted
May 2014
Primary outcomePrimary: 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 — 295; 301; 288; 292 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
295; 301; 288; 292 | — |
| 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 |
12.5; 8.8; 98.0; 99.0 | — |
| 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 |
25.0; 26.0; 97.0; 96.8 | — |
| 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 |
1.75; 1.45; 207; 223; 3.57; 3.65 | — |
| 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 |
1.71; 1.44; 203; 225 | — |
| 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 |
3.66; 3.64; 179; 191 | — |
| 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 |
82; 71; 1; 0; 44; 32 | — |
Eligibility Criteria
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:
- 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
- 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.
Data sourced from ClinicalTrials.gov (NCT01430611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.