Clinical Trial of Measles, Mumps and Rubella Combined Vaccine, Live

Shanghai Institute Of Biological Products

Status and phase

Completed

Phase 4

Conditions

Vaccine

Immunotoxicity

Treatments

Biological: Measles, Mumps and Rubella Combined Vaccine, Live

Study type

Interventional

Funder types

Industry

Identifiers

NCT05161845

SIBP-MMR-01

Details and patient eligibility

About

To evaluate the immunogenicity, lot-to-lot consistency and safety of three consecutive batches of Measles, Mumps and Rubella Combined Vaccine, Live.

Full 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.

Enrollment

1,068 patients

Sex

All

Ages

8 to 12 months old

Volunteers

Accepts Healthy Volunteers

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.