This is a phase IV, randomized, controlled, open-label study proceed in healthy children aged 8 months in China. The primary objective is to demonstrate the immunogenicity of simultaneous administration of JEV-I and MMR is not inferior to that of separate administration, as measured by seroconversion rates and antibody titers against the four antigens. The secondary objective is to describe the safety of the vaccines when administered simultaneously or separately.
According to current immunization programs in China, there is an overlap in the vaccination schedules for JEV-I and MMR. Children are recommended to receive 2 doses of JEV-I at 8 months of age, with an interval of 7-10 days. The MMR vaccine is also recommended for administration at 8 months of age. Administering JEV-I and MMR vaccines simultaneously at 8 months of age may facilitate adherence to vaccination programs, reduce the burden of medical treatment for parents and children who receive both vaccines separately, and improve the efficiency of vaccination work. This is a phase IV, randomized, controlled, open-label study proceed in healthy children aged 8 months in China. The primary objective is to demonstrate the immunogenicity of simultaneous administration of JEV-I and MMR is not inferior to that of separate administration, as measured by seroconversion rates and antibody titers against the four antigens. The secondary objective is to describe the safety of the vaccines when administered simultaneously or separately. The children aged 8 months who have not received any Japanese encephalitis vaccine or MMR (or vaccines containing related ingredients) will be recruited and randomly assigned to one of three study groups (1:1:1 ratio): Group 1, Group 2 and Group 3. Participants in Group 1 will receive JEV-I (dose 1) and MMR simultaneously for the first time. Participants in Group 2 will receive JEV-I only. Participants in Group 3 will receive MMR only. Blood will be collected pre-vaccination (Day 0) and 30 days post vaccination to evaluate seroconversion rates and antibody titers against the four antigens. After each vaccination, all participants will be observed at the clinical site for at least 30 minutes for immediate reactions and will be monitored for solicited adverse events (AEs) for 7 days post vaccination. All participants will be monitored for unsolicited AEs and serious adverse events within 30 days of post vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
408
0.5ml for each dose, manufactured by Liaoning Chengda Biotechnology CO., LTD, administered in the deltoid area of lateral arm by intramuscular injection.
0.5ml for each dose (after dissolving), manufactured by Shanghai Institute of Biological Products CO., LTD, administered in the lower part of the deltoid area of lateral arm, by subcutaneous injection.
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, China
Antibody Titer for Post Vaccination
The serum neutralizing antibody titer against Japanese encephalitis virus is measured by plaque reduction neutralization test (PRNT). The immunoglobulin (IgG) antibody titers against measles virus, mumps virus, and rubella virus are measured using enzyme-linked immunosorbent assay (ELISA).
Time frame: 30 days after the last dose of vaccination
Seroconversion Rate for Post Vaccination
The seroconversion rate for JEV-I post vaccination is defined as the percentage of participants with a change in serum anti-JE neutralizing antibody from PRNT titer \<1:10 at baseline to titer ≥1:10 30 days after the last dose of vaccination or a 4-fold rise from baseline. The seroconversion rate for MMR post vaccination is defined as the percentage of participants with a change in serum measles IgG antibody from titer \<200 milli international units (mIU)/mL at baseline to titer ≥200 mIU/mL post vaccination or a 4-fold rise from baseline, and serum mumps IgG antibody from titer \<100 international units (IU)/mL to titer ≥100 IU/mL or a 4-fold rise from baseline, and serum rubella IgG antibody from titer \<20 IU/mL to titer ≥20 IU/mL or a 4-fold rise from baseline, as measured by ELISA.
Time frame: 30 days after the last dose of vaccination
Incidence of Any Local and Systemic Adverse Events Within 30 Minutes of Each Vaccination
Participants will be observed at the clinical site for 30 minutes after each dose of vaccine. Any adverse events at the vaccination site (local) and non vaccination site (systemic) are collected. Adverse Events (AEs) are defined as all adverse medical events that occur in participants after receiving the investigational drug, which can manifest as symptoms, signs, diseases, or abnormal laboratory tests, but may not necessarily have a causal relationship with the investigational drug.
Time frame: 30 minutes following each vaccination
Incidence of Solicited Local and Systemic Adverse Events Within 7 Days of Each Vaccination
Parents use a structured diary card to record the following solicited (pre-listed) local and system reactions from 30 minutes through 7 days following vaccination: Local reactions: * Induration * Swelling * Rash * Tenderness Systemic reactions: * Fever * Diarrhea * Constipation * Dysphagia * Anorexia * Sickness * Vomiting * Syncope * Convulsions * Cough * Pruritus * Irritability or Sleepiness * Skin and mucosal abnormalities * Fatigue * Acute Allergic Reactions
Time frame: 30 minutes through 7 days following each vaccination
Incidence of Unsolicited Adverse Events and Serious Adverse Events Within 30 Days of Post Vaccination
Unsolicited adverse events and serious adverse events within 30 days of post vaccination will be collected through a combination of telephone visits by researchers and active reporting by participants. Serious adverse events are those meeting one of the following conditions: * Death * Life threatening * Resulted in a persistent or significant disability or incapacity * Required inpatient hospitalization or prolongation of existing hospitalization. * Congenital abnormalities or birth defects.
Time frame: 30 days of post vaccination
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