The clinical trial was designed to evaluate the safety and immunogenicity against Group ACYW135 Meningococcal Polysaccharide Vaccine of Hualan administered on subjects 2 years of age and older.
Complying with requirements of the approval letter of clinical trial issued by SFDA (Approval Letter No.: 2006L01017), Hualan conducted phase II clinical trial of Group ACYW135 Meningococcal Polysaccharide Vaccine to evaluate the safety and immunogenicity of the experimental vaccine. The safety end points were the presence of any systemic, local and adverse reaction. Evaluation indicators of immunogenicity were bacteriocin levels of groups A, C, Y and W135 respectively in the serum after the whole vaccination.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
360
360 subjects were divided into three groups (120 subjects in each group), children (2\~6 years of age), early youth (7\~15 years of age) and adult (16\~30 years of age) to receive Group ACYW135 Meningococcal Polysaccharide Vaccine, 0.5 ml, one dose regime
Safety
Systemic and local adverse reactions after the vaccination; adverse events
Time frame: Day 28 after vaccination
Immunogenicity
4-fold (seroconversion) and 8-fold increase of bactericidin; GMT and bactericidin increase after immunization
Time frame: The 4th week after immunization
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