This study is a randomized and controlled Phase IV clinical trial.The purpose of this study is to evaluate the immunogenicity and safety of combined immunization with live attenuated varicella vaccine and inactivated hepatitis A vaccine in children aged 12-15 months.
This study is a randomized and controlled phase IV clinical trial in children aged 1 year old (12-15 months).The purpose of this study is to evaluate the immunogenicity and safety of live attenuated varicella vaccine co-administration with inactivated hepatitis A vaccine .The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd,the inactivated hepatitis A vaccine was manufactured by Sinovac Biotech Co., Ltd.A total of 450 subjects aged 1 year old (12-15 months) were be enrolled.Subjects were be randomly divided into 2 groups in a ratio of 1:1.Subjects in the combined immunization group received one dose of live attenuated varicella vaccine and the first dose inactivated hepatitis A vaccine on day 0 and the second dose of inactivated hepatitis A vaccine on day 180.Subjects in the Non-combined immunization group received one dose of live attenuated varicella vaccine on day 0,the first dose of inactivated hepatitis A vaccine on day 42 and the second dose of inactivated hepatitis A vaccine on day 222.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
450
The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd,the inactivated hepatitis A vaccine was manufactured by Sinovac Biotech Co., Ltd. The live attenuated varicella vaccine:live varicella-zoster virus in 0.5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection. The inactivated hepatitis A vaccine:250 U inactivated virus in 0.5mL of aluminium hydroxide solution per injection. All subjects received hepatitis A vaccine in the upper left arm and varicella vaccine in the upper right arm.
Feicheng Center for Disease Control and Prevention
Tai’an, Shandong, China
Seroconversion rates of the varicella antibody
Seroconversion rate of varicella antibody 42 days after immunization of live attenuated varicella vaccine.
Time frame: 42 days after immunization of live attenuated varicella vaccine
Seroconversion rates of anti-HAV antibody
Seroconversion rate of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.
Time frame: 30 days after full immunization with hepatitis A vaccine
Seropositive rates of varicella antibody
Seropositive rates of varicella antibody 42 days after immunization of live attenuated varicella vaccine.
Time frame: 42 days after immunization of live attenuated varicella vaccine
GMT of varicella antibody
GMT of varicella antibody 42 days after immunization of live attenuated varicella vaccine.
Time frame: 42 days after immunization of live attenuated varicella vaccine
GMI of varicella antibody
GMI of varicella antibody 42 days after immunization of live attenuated varicella vaccine.
Time frame: 42 days after immunization of live attenuated varicella vaccine
Seropositive rates of anti-HAV antibody
Seropositive rates of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.
Time frame: 30 days after full immunization with hepatitis A vaccine
GMC of anti-HAV antibody
GMC of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.
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Time frame: 30 days after full immunization with hepatitis A vaccine
GMI of anti-HAV antibody
GMI of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.
Time frame: 30 days after full immunization with hepatitis A vaccine
The incidence of adverse events
Incidence of adverse events within 0-42 days (or 0-30 days) after each dose of vaccine.
Time frame: within 0-42 days (or 0-30 days) after each dose of vaccine
The incidence of local and systemic solicitation adverse reactions
The incidence of local and systemic solicitation adverse reactions within 0-14 days (or 0-7 days) after each dose of vaccine.
Time frame: Within 0-14 days (or 0-7 days) after each dose of vaccine
The incidence of serious adverse events (SAE)
The incidence of serious adverse events (SAE) within 42 days (or 30 days) after administration of each dose of vaccine.
Time frame: Within 42 days (or 30 days) after administration of each dose of vaccine