Immunotoxicity, Vaccine
Conditions
Keywords
MMR Combined Vaccines, safety, immunogenicity
Brief summary
To evaluate the immunogenicity, lot-to-lot consistency and safety of three consecutive batches of Measles, Mumps and Rubella Combined Vaccine, Live.
Detailed description
To assess Measles Mumps and Rubella Combined Vaccine, Live, (MMR) lot-to-lot consistency in healthy Chinese Children at the age of 8-12 months, and the participants randomized to receive one injections of 0.5 mL Measles, Mumps and Rubella Combined Vaccine, Live at day 0.
Interventions
0.5ml of reconstituted vaccine per container. 0.5 ml per single human dose containing not less than 3.0 lg CCID50 of both live measles virus and rubella virus and 4.3 lg CCID50 of live mumps virus.
Sponsors
Shanghai Institute Of Biological Products
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Months to 12 Months
Healthy volunteers
Yes
Inclusion criteria
Provide vaccination certificate and birth certificate for healthy children aged 8-12 months; * Volunteers' legal guardian informed consent, volunteered to participate and signed an informed consent form； * The volunteer's legal guardian has the ability to understand the research procedures, use the thermometer, scale and fill in the diary card as required, and can complete the clinical study in accordance with the requirements of the clinical trial protocol.
Exclusion criteria
* The axillary body temperature on the day of enrollment was more than 37.0 ℃; * Have suffered from measles, mumps and rubella in the past or are suffering from measles, mumps and rubella; * Any previous vaccination containing measles, mumps and rubella; * Persons known to be allergic to any ingredient in the investigational vaccine; * Any previous history of vaccine or drug allergy; * Premature (delivered before the 37th week of pregnancy) and low weight (birth weight \< 2500g); * History of dystocia, asphyxia rescue and nervous system damage; * Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc; * Acute disease, serious chronic disease or acute attack of chronic disease on the day of vaccination; * Have a history of live attenuated vaccine within 28 days before vaccination and other vaccines within 7 days; * Those who receive immune enhancement or inhibitor treatment within 3 months (continuous oral or drip for more than 14 days); * Suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases; * History of asthma, unstable in the past two years, requiring emergency treatment, hospitalization, intubation, oral or intravenous corticosteroids; * Have received blood or blood related products; * Patients with progressive nervous system diseases have a history of convulsion, epilepsy, encephalopathy, GuillainBarre syndrome, mental history or family history; * Have a history of abnormal coagulation function (such as coagulation factor deficiency and coagulation diseases); * Plan to move out before the end of the study or leave for a long time during the scheduled study visit; * Participating in or planning to participate in other clinical trials in the near future; * The investigator judges any situation that is not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The geometric mean concentrations (GMC) | 42 days | GMC of measles, mumps and rubella antibodies should be compared 42 days after vaccination, and detected by enzyme-linked immunosorbent assay (ELISA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The positive conversion rate of antibodies | 42 days | 1\. The positive conversion rate of antibodies to measles, mumps and rubella in each group 42 days after vaccination.The seroconversion rate refers to the proportion of subjects whose serum antibodies are negative before vaccination, which turn positive after vaccination, or serum antibodies are positive before vaccination, which increased by 4 times or more after vaccination. |
| The Seropositivity rate | 42 days | The seroprevalence rate refers to the proportion of subjects whose serum antibodies are positive. The cut-off for seropositivity for the antibody titers is as follows: 1. Anti-measles IgG antibody concentration by ELISA of \>200 mIU/mL. 2. Anti-mumps IgG antibody concentration by ELISA of \>100 U/mL. 3. Anti-rubella IgG antibody concentration by ELISA of \>20 IU/mL |
| The incidence of adverse events within 14 days | 14 days | The incidence of adverse events within 14 days after vaccination |
| All adverse events | 42 days | All adverse events from day 0 to 42 after vaccination |
| Serious adverse events | 180 days | Serious adverse events within 6 months after vaccination |
Countries
China
Outcome results
None listed