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

NCT ID: NCT05161845

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1068 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-23
• Study Completion Date: 2022-10-01

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.

Conditions

Immunotoxicity; Vaccine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental group

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

Group Type: EXPERIMENTAL

Measles, Mumps and Rubella Combined Vaccine, Live

Intervention Type: BIOLOGICAL

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.

Interventions

Measles, Mumps and Rubella Combined Vaccine, Live

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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 8 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Institute Of Biological Products

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongxing Pan

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Provincial Center for Disease Prevention and Control

Locations

Jiangsu Provincial Center for Disease Control and Prevention

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

SIBP-MMR-01

Identifier Type: -

Identifier Source: org_study_id