Clinical trial NCT05161845: Clinical Trial of Measles, Mumps and Rubella Combined Vaccine, Live
Official title: A Phase IV Randomized, Blinded Clinical Trial 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Immunotoxicity
Vaccine
Keywords: MMR Combined Vaccines
safety
immunogenicity
Lead sponsor: Shanghai Institute Of Biological Products
Sponsor class: INDUSTRY
First posted: 2021-12-17
Enrollment: 1068
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The geometric mean concentrations (GMC)
timeFrame: 42 days
Secondary outcomes:
measure: The positive conversion rate of antibodies
timeFrame: 42 days
measure: The Seropositivity rate
timeFrame: 42 days
measure: The incidence of adverse events within 14 days
timeFrame: 14 days
measure: All adverse events
timeFrame: 42 days
measure: Serious adverse events
timeFrame: 180 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial Center for Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: Jiangsu Provincial Center for Disease Prevention and Control
name: Hongxing Pan
role: PRINCIPAL_INVESTIGATOR
References: