Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Immunogenicity of Co-administration of Measles and Japanese Encephalitis Vaccines (MR+JE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02643433
Recruitment Status : Completed
First Posted : December 31, 2015
Last Update Posted : August 1, 2016
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Zhejiang Provincial Center for Disease Control and Prevention
Hubei Provincial Center for Disease Control and Prevention
Information provided by (Responsible Party):
Huaqing Wang, Centers for Disease Control and Prevention, China

Brief Summary:

Japanese encephalitis (JE) is the leading cause of viral neurological disease and disability in Asia. A live attenuated vaccine (LJEV) manufactured in China has several advantages over other JE vaccines such as one dose schedule, using for infants, and the cheaper cost. Because the LJEV has been prequalified by the World Health Organization (WHO) in 2013, it will likely be used in other countries, and possibly co-administered with the first dose of measles-containing vaccine (MCV) to ensure early protection and reduce additional vaccination visits.

The evidence for immunogenicity and safety of co-administration of LJEV with MCV is limited. Only one study conducted in the Philippines examining the co-administration of MCV with LJEV among 9 months infants, the results showed the proportion of achieved sero-protection against measles following MCV (96%) was slightly lower than in the MCV-only group (100%), and the measles antibody titres were also slightly lower in the co-administration group. Due to limited evidence available, the WHO position paper of measles vaccines has encouraged further investigation on the possible impact of co-administration of LJEV on measles vaccine effectiveness.

In China, Measles-Rubella combined vaccine (MR) and LJEV is given at 8 months of age nationally. Considering China is reaching towards the goal of measles elimination, it will be important to conduct a study to compare the immunogenicity of MR administered alone or with LJEV, and also evaluate the safety and tolerability of LJEV administered with MR among 8 months infants.

This study is a prospective, randomized, open-label, multi-center study enrolling infants aged 8 months. Basic demographic information of the infant will be taken and blood samples will be collected at enrollment (baseline) and at 6weeks following administration of MR, the measles antibodies will be measured, and compare seroconversion rates to assess for non-inferiority. All infants will be monitored for adverse events after MR.


Condition or disease Intervention/treatment Phase
Measles Rubella Japanese Encephalitis Biological: Measles-Rubella combined vaccine(MR) Biological: Japanese Encephalitis alive vaccine(JE) Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1043 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity of Co-administration of Measles Containing Vaccine and Japanese Encephalitis Alive Vaccines
Study Start Date : August 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MR and JE coadministration group
Infants aged 8 months are vaccinated measles-rubella combined vaccine (MR) and Japanese Encephalitis alive vaccine (JE) in different sites at same time.
Biological: Measles-Rubella combined vaccine(MR)
0.5ml for each dose,be administered by single use syringe subcutaneously in the lower part of the deltoid area of lateral arm.

Biological: Japanese Encephalitis alive vaccine(JE)
0.5ml for each dose be administered by single use syringe subcutaneously in the lower part of the deltoid area of lateral arm.

Active Comparator: MR administration alone group
Infants aged 8 months are vaccinated measles-rubella combined vaccine alone
Biological: Measles-Rubella combined vaccine(MR)
0.5ml for each dose,be administered by single use syringe subcutaneously in the lower part of the deltoid area of lateral arm.




Primary Outcome Measures :
  1. Seroconversion rate for measles [ Time Frame: 6 weeks after vaccination (day 42-48) ]
    Compare the seroconversion rate of measles antibody between the two groups


Secondary Outcome Measures :
  1. Seroconversion rate for rubella [ Time Frame: 6 weeks after vaccination (day 42-48) ]
    Compare the seroconversion rate of rubella antibody between the two groups

  2. Adverse Events Following Immunization [ Time Frame: Within 6 weeks after vaccination ]
    Compare the rate of Adverse Events Following Immunization between the two groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Months to 9 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Infants between 8 months and 8 months plus two weeks of age;
  2. Complete vaccination of national immunization schedule before 8 months;
  3. Healthy infants;
  4. Live in the study county with good compliance who can participate in the entire observation period.

Exclusion Criteria:

  1. Previous history of measles, rubella, or JE;
  2. Previously received vaccines containing measles/rubella or JE components;
  3. Contraindications to the study vaccines;
  4. Received blood products or immunosuppressive treatments within last 3 months;
  5. Received any live attenuated vaccines within the last 4 weeks, or any inactivated vaccines within 2 weeks;
  6. Guardian refuses to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643433


Locations
Layout table for location information
China, Hebei
Hebei Provincial Center for Disease Control and Prevention
Shijiazhuang, Hebei, China
China, Zhejiang
Zhejiang Provincial Center for Disease Control and Prevention
Hangzhou, Zhejiang, China
Sponsors and Collaborators
Centers for Disease Control and Prevention, China
Centers for Disease Control and Prevention
Zhejiang Provincial Center for Disease Control and Prevention
Hubei Provincial Center for Disease Control and Prevention
Investigators
Layout table for investigator information
Principal Investigator: Huaqing Wang, MD, PhD Centers for Disease Control and Prevention, China
Study Director: Zhijie AN, MD, MPH Centers for Disease Control and Prevention, China
Study Chair: Zijian Feng, MD, MPH Centers for Disease Control and Prevention, China

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Huaqing Wang, Deputy Director, National Immunization Program, China CDC, Centers for Disease Control and Prevention, China
ClinicalTrials.gov Identifier: NCT02643433     History of Changes
Other Study ID Numbers: 201518
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: August 1, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: we will share the serum results with the participants after completing laboratory test. and we will publish articles to share our research.
Keywords provided by Huaqing Wang, Centers for Disease Control and Prevention, China:
Immunogenicity
Coadministration
Measles
Rubella
Japanese encephalitis
Vaccine
Additional relevant MeSH terms:
Layout table for MeSH terms
Measles
Rubella
Encephalitis, Japanese
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Rubivirus Infections
Togaviridae Infections
Encephalitis, Arbovirus
Arbovirus Infections
Encephalitis, Viral
Central Nervous System Viral Diseases
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs