Immunogenicity of Co-administration of Measles and Japanese Encephalitis Vaccines (MR+JE)
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ClinicalTrials.gov Identifier: NCT02643433 |
Recruitment Status :
Completed
First Posted : December 31, 2015
Last Update Posted : August 1, 2016
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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 |
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Measles Rubella Japanese Encephalitis | Biological: Measles-Rubella combined vaccine(MR) Biological: Japanese Encephalitis alive vaccine(JE) | Phase 4 |

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 |

Arm | Intervention/treatment |
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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.
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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
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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. |
- Seroconversion rate for measles [ Time Frame: 6 weeks after vaccination (day 42-48) ]Compare the seroconversion rate of measles antibody between the two groups
- Seroconversion rate for rubella [ Time Frame: 6 weeks after vaccination (day 42-48) ]Compare the seroconversion rate of rubella antibody between the two groups
- Adverse Events Following Immunization [ Time Frame: Within 6 weeks after vaccination ]Compare the rate of Adverse Events Following Immunization between the two groups

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Ages Eligible for Study: | 8 Months to 9 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Infants between 8 months and 8 months plus two weeks of age;
- Complete vaccination of national immunization schedule before 8 months;
- Healthy infants;
- Live in the study county with good compliance who can participate in the entire observation period.
Exclusion Criteria:
- Previous history of measles, rubella, or JE;
- Previously received vaccines containing measles/rubella or JE components;
- Contraindications to the study vaccines;
- Received blood products or immunosuppressive treatments within last 3 months;
- Received any live attenuated vaccines within the last 4 weeks, or any inactivated vaccines within 2 weeks;
- Guardian refuses to participate in the study.

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
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 |
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Huaqing Wang, Deputy Director, National Immunization Program, China CDC, Centers for Disease Control and Prevention, China |
ClinicalTrials.gov Identifier: | NCT02643433 |
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. |
Immunogenicity Coadministration Measles |
Rubella Japanese encephalitis Vaccine |
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 |