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Study on Immunization Schedule of Beijing Tiantan Biological's Measles-mumps-rubella(MMR) Vaccine

Primary Purpose

Measles, Mumps, Rubella

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Measles, mumps and rubella Combined Vaccine, Live
Sponsored by
Centers for Disease Control and Prevention, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Measles

Eligibility Criteria

18 Months - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy children; 150 subjects 18 months old; 150 subjects 4 years old;300 subjects 5 years old; 150 subjects 6 years old; their guardians signed informed consent;
  • undiagnosed as measles, mumps and rubella;
  • in good health as determined by the outcome of medical history, physical examination and clinical judgment; suitable to MMR immunization;
  • guardians would comply with the requirements of the protocol;
  • immunized with MR or measles vaccine(MV) at 8 months old;immunized with MMR at 18 months old(not applicable to subjects 18 months old); unvaccinated by biological products within one month;
  • Axillary temperature ≤37℃;
  • the local household population or permanent population;

Exclusion Criteria:

  • history of allergic disease or reactions likely to be exacerbated by any component of the vaccine(any previous vaccination history of allergies and egg allergy history);
  • Current confirmed as acute disease, severe chronic diseases or acute development of chronic diseases;
  • Participating in another clinical trial at the same time;

Sites / Locations

  • Hebei Provincial Center for Disease Control and Prevention
  • Inner Mongolia Center for Disease Control and Prevention
  • Shanxi Provincial Center for Disease Control and Prevention
  • Tianjin Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

one dose of MMR

30 months after two doses of MMR

42 months after two doses of MMR

54 months after two doses of MMR

Arm Description

Subjects are vaccinated with MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 months old.

Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 4 years old, sequentially.

Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 5 years old, sequentially.

Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 6 years old, sequentially.

Outcomes

Primary Outcome Measures

Immunogenicity of the MMR vaccines in terms of antibody concentration
For measles virus, seroresponse is defined as post-vaccination anti-measles virus antibody concentration (Ab conc) >200 mIU/mL. For mumps virus, seroresponse is defined as post-vaccination anti-mumps virus Ab conc >100 IU/mL. For rubella virus, seroresponse is defined as post-vaccination anti-rubella virus Ab conc >20 IU/mL.

Secondary Outcome Measures

Full Information

First Posted
May 10, 2017
Last Updated
May 17, 2017
Sponsor
Centers for Disease Control and Prevention, China
Collaborators
Beijing Tiantan Biological Products Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03160820
Brief Title
Study on Immunization Schedule of Beijing Tiantan Biological's Measles-mumps-rubella(MMR) Vaccine
Official Title
Comparison of Immunization Schedules of Beijing Tiantan Biological's MMR Vaccine in 18-72 Month-Old Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centers for Disease Control and Prevention, China
Collaborators
Beijing Tiantan Biological Products Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the immunogenicity and safety of Beijing Tiantan's MMR vaccine in subjects 18 months of age and older. The MMR vaccine may be administered as a second dose to 4-6 year-old persons with one dose immunization with MMR vaccine or as a first dose to 18 month-old subjects with one dose immunization with measles-rubella(MR).
Detailed Description
This study will evaluate the immunogenicity and safety of Beijing Tiantan's MMR vaccine in subjects 18 months of age and older. The MMR vaccine may be administered as a second dose to 4-6 year-old persons with one dose immunization with MMR vaccine or as a first dose to 18 month-old subjects with one dose immunization with MR. Immune efficacy and safety will be compared among different immunization schedules,including inoculation doses,enhanced immunity age,vaccination interval time. Antibody persistence of 1 dose of MMR vaccine will be evaluated in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Measles, Mumps, Rubella, Adverse Event Following Immunisation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
873 (Actual)

8. Arms, Groups, and Interventions

Arm Title
one dose of MMR
Arm Type
Other
Arm Description
Subjects are vaccinated with MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 months old.
Arm Title
30 months after two doses of MMR
Arm Type
Other
Arm Description
Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 4 years old, sequentially.
Arm Title
42 months after two doses of MMR
Arm Type
Other
Arm Description
Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 5 years old, sequentially.
Arm Title
54 months after two doses of MMR
Arm Type
Other
Arm Description
Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 6 years old, sequentially.
Intervention Type
Biological
Intervention Name(s)
Measles, mumps and rubella Combined Vaccine, Live
Other Intervention Name(s)
Beijing Tiantan Biological Products Co., Ltd
Intervention Description
Subjects will be inoculated one dose of MMR vaccine and collected blood samples before and after vaccination.
Primary Outcome Measure Information:
Title
Immunogenicity of the MMR vaccines in terms of antibody concentration
Description
For measles virus, seroresponse is defined as post-vaccination anti-measles virus antibody concentration (Ab conc) >200 mIU/mL. For mumps virus, seroresponse is defined as post-vaccination anti-mumps virus Ab conc >100 IU/mL. For rubella virus, seroresponse is defined as post-vaccination anti-rubella virus Ab conc >20 IU/mL.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy children; 150 subjects 18 months old; 150 subjects 4 years old;300 subjects 5 years old; 150 subjects 6 years old; their guardians signed informed consent; undiagnosed as measles, mumps and rubella; in good health as determined by the outcome of medical history, physical examination and clinical judgment; suitable to MMR immunization; guardians would comply with the requirements of the protocol; immunized with MR or measles vaccine(MV) at 8 months old;immunized with MMR at 18 months old(not applicable to subjects 18 months old); unvaccinated by biological products within one month; Axillary temperature ≤37℃; the local household population or permanent population; Exclusion Criteria: history of allergic disease or reactions likely to be exacerbated by any component of the vaccine(any previous vaccination history of allergies and egg allergy history); Current confirmed as acute disease, severe chronic diseases or acute development of chronic diseases; Participating in another clinical trial at the same time;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiang Wu
Organizational Affiliation
Beijing Center for Diseases Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hebei Provincial Center for Disease Control and Prevention
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050021
Country
China
Facility Name
Inner Mongolia Center for Disease Control and Prevention
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010031
Country
China
Facility Name
Shanxi Provincial Center for Disease Control and Prevention
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030012
Country
China
Facility Name
Tianjin Center for Disease Control and Prevention
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300011
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study on Immunization Schedule of Beijing Tiantan Biological's Measles-mumps-rubella(MMR) Vaccine

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