This is a phase Ⅳ clinical trial of live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.The primary objective of this study is to evaluate the immunogenicity of live attenuated varicella vaccine co-administered with MMR vaccine or DTaP vaccine. The secondary objective is to evaluate the safety of the vaccines when administered simultaneously.
A total of 720 children aged 18\~24 months who have not received varicella vaccine, the second dose of MMR and the fourth dose of DTaP (or vaccines containing related ingredients) will be recruited and randomly assigned to one of three study groups (1:1:1 ratio): Group A, Group B and Group C. Participants in Group A will receive varicella vaccine and DTaP simultaneously on Day 0 and receive MMR on Day 30. Participants in Group B will varicella vaccine and MMR simultaneously on Day 0 and receive DTaP on Day 30. Participants in Group C will receive varicella vaccine only.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
720
Varicella vaccine: lyophilized powder, subcutaneous injection DTaP: intramuscular injection MMR: lyophilized powder, subcutaneous injection
Varicella vaccine: lyophilized powder, subcutaneous injection MMR: lyophilized powder, subcutaneous injection DTaP: intramuscular injection
lyophilized powder, subcutaneous injection
Chongqing Center for Disease Control and Prevention
Chongqing, China
Varicella zoster virus (VZV) antibody seroconversion rate
Seroconversion rate of VZV antibody on Day 30 after the administration of varicella vaccine.
Time frame: Day 30 after the administration of varicella vaccine
Seropositive rate of VZV antibody
Seropositive rate of VZV antibody on Day 30 after the administration of varicella vaccine.
Time frame: Day 30 after the administration of varicella vaccine
Geometric mean titer (GMT) of VZV antibody
GMT of VZV antibody on Day 30 after the administration of varicella vaccine.
Time frame: Day 30 after the administration of varicella vaccine
Geometric mean fold increase (GMI) of VZV antibody
GMI of VZV antibody on Day 30 after the administration of varicella vaccine.
Time frame: Day 30 after the administration of varicella vaccine
Seroconversion rate of measles antibody, mumps antibody and rubella antibody
Seroconversion rate of measles antibody, mumps antibody and rubella antibody on Day 30 after the administration of MMR
Time frame: Day 30 after the administration of MMR
Seropositive rate of measles antibody, mumps antibody and rubella antibody
Seropositive rate of measles antibody, mumps antibody and rubella antibody on Day 30 after the administration of MMR
Time frame: Day 30 after the administration of MMR
Geometric mean concentration (GMC) of measles antibody, mumps antibody and rubella antibody
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GMC of measles antibody, mumps antibody and rubella antibody on Day 30 after the administration of MMR
Time frame: Day 30 after the administration of MMR
GMI of measles antibody, mumps antibody and rubella antibody
GMI of measles antibody, mumps antibody and rubella antibody on Day 30 after the administration of MMR
Time frame: Day 30 after the administration of MMR
Seroconversion rate of pertussis antibody, diphtheria antibody and tetanus antibody
Seroconversion rate of pertussis antibody, diphtheria antibody and tetanus antibody on Day 30 after the administration of DTaP
Time frame: Day 30 after the administration of DTaP
Seropositive rate of pertussis antibody, diphtheria antibody and tetanus antibody
Seropositive rate of pertussis antibody, diphtheria antibody and tetanus antibody on Day 30 after the administration of DTaP
Time frame: Day 30 after the administration of DTaP
GMC of pertussis antibody, diphtheria antibody and tetanus antibody
GMC of pertussis antibody, diphtheria antibody and tetanus antibody on Day 30 after the administration of DTaP
Time frame: Day 30 after the administration of DTaP
GMI of pertussis antibody, diphtheria antibody and tetanus antibody
GMI of pertussis antibody, diphtheria antibody and tetanus antibody on Day 30 after the administration of DTaP
Time frame: Day 30 after the administration of DTaP
The incidence of adverse reactions within 0~14 days
The incidence of adverse reactions within 0\~14 days after each dose vaccination.
Time frame: 0~14 days after each dose vaccination
The incidence of adverse reactions within 0~30 days
The incidence of adverse reactions within 0\~30 days after each dose vaccination.
Time frame: 0~30 days after each dose vaccination
The incidence of serious adverse events (SAEs) within 0~30 days
The incidence of SAEs within 0\~30 days after each dose vaccination.
Time frame: 0~30 days after each dose vaccination