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

Primary Purpose

Immunotoxicity, Vaccine

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Measles, Mumps and Rubella Combined Vaccine, Live
Sponsored by
Shanghai Institute Of Biological Products
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Immunotoxicity focused on measuring MMR Combined Vaccines, safety, immunogenicity

Eligibility Criteria

8 Months - 12 Months (Child)All SexesAccepts 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.

Sites / Locations

  • Jiangsu Provincial Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental group

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

The positive conversion rate of antibodies
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.
The Seropositivity rate
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: Anti-measles IgG antibody concentration by ELISA of >200 mIU/mL. Anti-mumps IgG antibody concentration by ELISA of >100 U/mL. Anti-rubella IgG antibody concentration by ELISA of >20 IU/mL
The incidence of adverse events within 14 days
The incidence of adverse events within 14 days after vaccination
All adverse events
All adverse events from day 0 to 42 after vaccination
Serious adverse events
Serious adverse events within 6 months after vaccination

Full Information

First Posted
December 5, 2021
Last Updated
August 10, 2023
Sponsor
Shanghai Institute Of Biological Products
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1. Study Identification

Unique Protocol Identification Number
NCT05161845
Brief Title
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 23, 2021 (Actual)
Primary Completion Date
April 4, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Institute Of Biological Products

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunotoxicity, Vaccine
Keywords
MMR Combined Vaccines, safety, immunogenicity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1068 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Participants randomized to receive one injections of 0.5 mL Measles, Mumps and Rubella Combined Vaccine, Live at Day 0.
Intervention Type
Biological
Intervention Name(s)
Measles, Mumps and Rubella Combined Vaccine, Live
Intervention Description
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.
Primary Outcome Measure Information:
Title
The geometric mean concentrations (GMC)
Description
GMC of measles, mumps and rubella antibodies should be compared 42 days after vaccination, and detected by enzyme-linked immunosorbent assay (ELISA).
Time Frame
42 days
Secondary Outcome Measure Information:
Title
The positive conversion rate of antibodies
Description
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.
Time Frame
42 days
Title
The Seropositivity rate
Description
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: Anti-measles IgG antibody concentration by ELISA of >200 mIU/mL. Anti-mumps IgG antibody concentration by ELISA of >100 U/mL. Anti-rubella IgG antibody concentration by ELISA of >20 IU/mL
Time Frame
42 days
Title
The incidence of adverse events within 14 days
Description
The incidence of adverse events within 14 days after vaccination
Time Frame
14 days
Title
All adverse events
Description
All adverse events from day 0 to 42 after vaccination
Time Frame
42 days
Title
Serious adverse events
Description
Serious adverse events within 6 months after vaccination
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongxing Pan
Organizational Affiliation
Jiangsu Provincial Center for Disease Prevention and Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiangsu Provincial Center for Disease Control and Prevention
City
Nanjing
State/Province
Jiangsu
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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