Meningitis
Conditions
Keywords
Immunogenicity, Safety, Meningococcal Conjugate Vaccine
Brief summary
The purpose of this observer-blind study is to evaluate the safety, reactogenicity and immunogenicity of Meninggococcal (A,C,Y and W135) Conjugate Vaccine in 2 months to 6 years-old children.
Interventions
BIOLOGICALMCV-ACYW135 Vaccine Group
0.5ml, intramuscular
BIOLOGICALMPV-ACYW135 Vaccine Group
0.5ml, intramuscular
BIOLOGICALMPV-A Vaccine Group
0.5ml, intramuscular
BIOLOGICALMCV-AC Vaccine Group
0.5ml, intramuscular
BIOLOGICALHib Vaccine Group
0.5ml, intramuscular
Sponsors
Beijing Minhai Biotechnology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study. * Healthy permanent residence 2 months to 6 years old. * Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures. * Axillary temperature ≤37.0 ℃.
Exclusion criteria
* History of meningitis infection or vaccination of meningococcal vaccine within the past 6 months. * Allergic history or any SAE after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia. * Patients administered with immunosuppressive agents, cytotoxicity factor or corticosteroids in the 6 months preceding the vaccine trial. * Receipt of blood or blood-derived products in the 3 months preceding vaccination * Participation in another clinical study investigating a vaccine, drug in the 30 days preceding vaccination. * Receipt of any live virus vaccine in the 15 days preceding vaccination. * Receipt of any subunit vaccine and inactivated vaccine in the 7 days before vaccination. * Febrile illness (temperature ≥ 38°C) in the 3 days or any acute illness/infection in the 7 days preceding vaccination. * Thrombocytopenia. * History of thyroid gland excision or treatment for thyroid gland disease in last 12 months. * Functional or anatomic asplenia. * History of eclampsia, epilepsy, encephalopathy and mental disease or family disease. * Chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease, Guillain-Barre Syndrome). * Known or suspected diseases, including: respiratory system disease, acute infection or active stage of chronic disease, HIV infection of children or mothers, cardiovascular disease, acute hypertension, cancer treatment, skin disease, etc. * Any condition that, in the judgment of investigator, may affect trial assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects exhibiting a >= 4fold increase in rSBA titers level from pre-vaccination to post-vaccination | 28 days after vaccination |
Secondary
| Measure | Time frame |
|---|---|
| to evaluate the adverse reactions after vaccination | Within 28 days after vaccination |
Countries
China
Outcome results
None listed