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

NCT05161845 | Completed Phase 4

• 1 other identifier: SIBP-MMR-01
• Study Type: interventional
• Target: 1,068
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Immunotoxicity; Vaccine

Keywords

MMR Combined Vaccines; safety; immunogenicity

Outcome Measures

Primary Outcomes (1)

• The geometric mean concentrations (GMC)

  GMC of measles, mumps and rubella antibodies should be compared 42 days after vaccination, and detected by enzyme-linked immunosorbent assay (ELISA).

  42 days

Secondary Outcomes (5)

• The positive conversion rate of antibodies

  42 days

• The Seropositivity rate

  42 days

• The incidence of adverse events within 14 days

  14 days

• All adverse events

  42 days

• Serious adverse events

  180 days

Study Arms (1)

Experimental group

EXPERIMENTAL

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

Biological: Measles, Mumps and Rubella Combined Vaccine, Live

Interventions

Measles, Mumps and Rubella Combined Vaccine, Live 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.

Experimental group

Eligibility Criteria

• Age: 8 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Institute Of Biological Products: lead

Study Sites (1)

Jiangsu Provincial Center for Disease Control and Prevention

Nanjing, Jiangsu, China

Location

Study Officials

• Hongxing Pan

  Jiangsu Provincial Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: December 17, 2021
• Study Start: December 23, 2021
• Primary Completion: April 4, 2022
• Study Completion: October 1, 2022
• Last Updated: August 14, 2023

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)