Meningitis, Meningococcal Infections, Meningococcal Meningitis
Conditions
Brief summary
To evaluate Immunogenicity and Safety of Adjuvant and Adjuvant-Free Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age. Primary objective: * To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C and Haemophilus influenzae type b following the administration of adjuvant-free MenAC-Hib conjugate vaccine compared to those observed following the administration of adjuvant MenAC-Hib conjugate vaccine. * To describe the safety profile of adjuvant-free MenAC-Hib conjugate vaccine compared to that of adjuvant MenAC-Hib conjugate vaccine. Secondary objective: •To compare the antibody level of meningococcal serogroups A, C and Haemophilus influenzae type b following the administration of adjuvant-free MenAC-Hib conjugate vaccine to those observed following the administration of adjuvant MenAC-Hib conjugate vaccine.
Interventions
BIOLOGICALMeningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free)
30μg /dose, Intramuscular
BIOLOGICALMeningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant)
0.5ml /dose, Intramuscular
Sponsors
Guangdong Center for Disease Prevention and Control
Guizhou Center for Disease Control and Prevention
National Institutes for Food and Drug Control, China
Air Force Military Medical University, China
Simoon Record Pharma Information Consulting Co., Ltd.
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
2 Months to 5 Months
Healthy volunteers
Yes
Inclusion criteria
* Health infants aged 2 to 5 months. * Legal guardian has signed written informed consent. * Guardian may finish the whole visit in the judgment of investigator. * 2-5 months health infants who haven't immuned with any Meningococcal A and C Conjugate Vaccine or Haemophilus b Conjugate Vaccine. * Subject who did't vaccinated with any live vaccine within 14 days or inactivated vaccine within 10 days before vaccination.
Exclusion criteria
* Fever, body temperature ≥37.1℃. * History of severe allergic reaction that needs medical intervention including throat swelling, dyspnea, hypotension or shock; History of allergic reaction to vaccine or to any of the vaccine components especially to tetanus toxoid or history of other severe adverse reaction to vaccine. * Clear diagnosis of thrombocytopenia or history of other coagulation disorders that may cause contraindications of intramuscular injection. * Subject with history of abnormal labor, asphyxia rescue history,congenital malformations,eccyliosis or severe chronic disease. * Severe cardiovascular or liver and kidney disease, active tuberculosis and HIV infection. * Subject with encephalopathy, uncontrolled epilepsy and other progressive nervous system disease. * Subject suffer from acute disease, severe chronic disease, acute episode of chronic disease and febrile illness (temperature ≥ 38°C) within 3 days. * Any condition that, in the judgment of investigator, subject is not suitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with seroresponse to meningococcal serogroups A,C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine | Day 30 post-vaccination |
| Occurrence of adverse events during a 30 day follow-up period after each vaccination | 30 day after each vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of severe adverse events within six months post-vaccination | six months post-vaccination |
| Geometric mean titer （GMT）of antibodies against meningococcal serogroups A, C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine | Day 30 post-vaccination |
Countries
China
Contacts
Primary ContactZeng peiyu, Bachelor
Outcome results
None listed