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Safety of Vero Cell - Derived Inactivated Japanese Encephalitis Vaccine (JECEVAX) in Children From 9-24 Months of Age (JECEVAX-2B)

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: NCT03204227
Recruitment Status : Completed
First Posted : June 29, 2017
Last Update Posted : September 17, 2018
Sponsor:
Collaborators:
Ministry of Science and Technology, Vietnam
Ministry of Health, Vietnam
Information provided by (Responsible Party):
Vu Dinh Thiem, National Institute of Hygiene and Epidemiology, Vietnam

Brief Summary:
A study of the study vaccine (JECEVAX- VABIOTECH-Vietnam) and a licensed vaccine (JEVAX-VABIOTECH-Vietnam) is conducted in Vietnamese children, aged 9 to 24 months to assess the safety of the study vaccine compares to licenced vaccine. Two hundred and twenty children are enrolled and randomly assigned into 2 groups (110 children/group), each of which receive 2 doses of study / control vaccine subcutaneously, at 28-34 days interval. Safety data included immediate reaction at the injection site and systemic reaction within 30 min of administration, solicited and unsolicited adverse events occurs from the 1st dose to 28-34 days after first dose and from the second dose to 28-34 days after 2nd dose. SAE (from start of first dose to 28-34 days after second dose).

Condition or disease Intervention/treatment Phase
Japanese Encephalitis Biological: JEVAX Biological: JECEVAX Phase 2

Detailed Description:

Mouse brain-derived Japanese Encephalitis (JE) vaccine was developed in Vietnam since 1989 with the support from WHO and BIKEN institute, Japan. It helped Viet Nam prevents Japanese Encephalitis outbreaks successfully during those years.

However, mouse brain-derived JE vaccine production requires companies to compliance various requirements from WHO. Especially, WHO has a plan to replace the mouse brain-derived JE vaccines with Cell culture-derived JE vaccines.

Vero cell-derived vaccine technology shows many advantages compares to Mouse brain-derived vaccine technology. VABIOTECH has been approved and sponsored by the Ministry of Science and Technology to produce Vero cell - derived JE vaccine. The vaccine demonstrated a good safety and immunogenicity profile in animal models. The vaccine has been proven safety in volunteer adults and in phase 2 which evaluated the safety and immunogenicity of 3 difference antigen concentrations.

In this study, a selected dose of the studied vaccine (JECEVAX) derived from phase 2 will be compared the safety with a licensed vaccine (JEVAX-VABIOTECH Vietnam) in Vietnamese children, aged 9-24 months to assess the safety and immunogenicity. Two hundred and twenty children are enrolled and randomly assigned into 2 groups (110 children/group), each of which receive 2 doses of investigate vaccines or control vaccine subcutaneously, at 28-34 days interval. Safety data included immediate reaction at the injection site and systemic reaction within 30 min of administration, solicited and unsolicited adverse events occurs from the 1st dose to 28-34 days after first dose (up to date of 2nd dose) and from the second dose to 28-34 days after 2nd dose (up to date of 3rd visit). SAE (from start of first dose to 28-34 days after second dose - date of 3rd visit).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluate the Safety of a Vero Cell - Derived Inactivated Japanese Encephalitis Vaccine (JECEVAX) Produced by The Company for Vaccine and Biological Production No.1 in Vietnamese Children Aged 9-24 Months
Actual Study Start Date : June 2, 2017
Actual Primary Completion Date : August 12, 2017
Actual Study Completion Date : August 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis
Drug Information available for: Ixiaro JE-Vax

Arm Intervention/treatment
Experimental: JECEVAX
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 28-34 days
Biological: JECEVAX
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 28-34 days

Active Comparator: JEVAX
JEVAX - VABIOTECH Vietnam Liquid form Composition: 1,0 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 28-34 days
Biological: JEVAX
JEVAX - VABIOTECH Vietnam Liquid form Subcutaneous injection 0.5ml/dose, 2 doses, 28-34 days interval




Primary Outcome Measures :
  1. Percent of participants with treatment-related adverse events during study period. [ Time Frame: Up to 28-34 days after 2nd dose ]
    Percent of participants with solicited and unsolicited adverse events after each dose of vaccine: immediately injection site and systemic AEs after vaccination (within 30 min), solicited AEs within 7 days after each dose, unsolicited AEs from date 1st dose 1 to date of dose 2 and from date of 2nd dose to 28-34 day post 2nd dose (3rd visit), as assessed by CTCAE v.4.0.


Secondary Outcome Measures :
  1. Frequencies of participants with treatment-related SAE during study period [ Time Frame: Up to 28-34 days after the 2nd dose (3rd visit) ]
    Frequencies of participants with treatment-related SAE during study period of JECEVAX compared to that of JEVAX, as assessed by CTCAE ver 4.0



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy children of both sexes, 9-24 months of age;
  • Have not been vaccinated with JE vaccine;
  • Parents/legally guardians agree their children to participate in the study and sign the paper informed consent.

Exclusion Criteria:

  • Currently has chronic diseases (cardiovascular, liver and spleen related etc);
  • Currently has acute diseases;
  • Use of immunocompromised treatment within 4 weeks of enrollment;
  • Being immunocompromised and autoimmune diseases (HIV, lupus);
  • The family history of immunocompromised;
  • History of febrile seizure;
  • Allergic to any vaccine component;
  • Fever (>38 Celsius degree) within 3 days before vaccination or at enrollment;
  • Malnourished (2nd grade or above);
  • Blood disorder;
  • Use of vaccines which have not been licenced 7 days before enrolment in this 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): NCT03204227


Locations
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Vietnam
Hoa Binh Provincial Preventive Medicine Center
Hòa Bình, Hoa Binh, Vietnam, 350000
Hoa Binh City Health Center
Hòa Bình, Hoa Binh, Vietnam, 35000
District Health Center
Thanh Son, Phu Tho, Vietnam
Phu Tho Preventive Medicine Center
Viet tri, Phu Tho, Vietnam
Sponsors and Collaborators
National Institute of Hygiene and Epidemiology, Vietnam
Ministry of Science and Technology, Vietnam
Ministry of Health, Vietnam
Investigators
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Principal Investigator: Thiem D Vu, MD., PhD. National Institute of Hygiene and Epidemiology, Vietnam

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Responsible Party: Vu Dinh Thiem, Head, Department of Epidemiology, National Institute of Hygiene and Epidemiology, Vietnam
ClinicalTrials.gov Identifier: NCT03204227     History of Changes
Other Study ID Numbers: 2017-JECEVAX-2B
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Individual data with identification removed are to be available for Ethical committee, Ministry of Health and National Foundation of Science and Technology Development to avoid misuse of data.

Public shared data will be in the form of summarised tables and figures.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vu Dinh Thiem, National Institute of Hygiene and Epidemiology, Vietnam:
Japanese Encephalitis
JECEVAX
Vietnam

Additional relevant MeSH terms:
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Encephalitis, Japanese
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections