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

Phase 4

Completed

• Conditions: Immunotoxicity; Vaccine
• Interventions: Biological: Measles, Mumps and Rubella Combined Vaccine, Live

• Registration Number: NCT05161845
• Lead Sponsor: Shanghai Institute Of Biological Products

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.

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-05
• Study First Submitted QC: 2021-12-05
• Study First Posted: 2021-12-17
• Study Start: 2021-12-23
• Primary Completion: 2022-04-04
• Study Completion: 2022-10-01
• Last Update Submitted: 2023-08-10
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1068

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Measles, Mumps and Rubella Combined Vaccine, Live	Participants randomized to receive one injections of 0.5 mL Measles, Mumps and Rubella Combined Vaccine, Live at Day 0.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Serious adverse events	180 days	Serious adverse events within 6 months after vaccination
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
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

Trial Locations

Locations (1)

Jiangsu Provincial Center for Disease Control and Prevention; 🇨🇳 Nanjing, Jiangsu, China