Evaluate Safety and Immunogenicity of a Vero Cell-Derived JE Vaccine in 9-24 Months of Age Children in Vietnam

NCT03282370 | Completed Phase 3 DMC

• 1 other identifier: 2017-JECEVAX-3
• Study Type: interventional
• Target: 655
• Locations: 1 country
• Sites: 4

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).

Conditions

Japanese Encephalitis

Keywords

Japanese Encephalitis; JECEVAX; Vietnam

Outcome Measures

Primary Outcomes (2)

• Percent of participants with treatment-related adverse events during study period.

  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.

  Up to 28-34 days after 2nd dose

• Percent of participants who has antibody sero-conversion in study group and control group at 28-34 days post dose 2.

  Serum samples will be taken before 1 dose and 28-34 days post 2nd dose to be tested for JE antibody by PRNT.

  Up to 28-34 days after 2nd dose

Secondary Outcomes (1)

• Frequencies of participants with treatment-related SAE during study period

  Up to 28-34 days after the 2nd dose (3rd visit)

Study Arms (2)

JECEVAX

EXPERIMENTAL

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

Biological: JECEVAX

JEVAX

ACTIVE COMPARATOR

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

Biological: JEVAX

Interventions

JEVAX BIOLOGICAL

JEVAX - VABIOTECH Vietnam Liquid form Subcutaneous injection 0.5ml/dose, 2 doses, 28-34 days interval

JEVAX

JECEVAX BIOLOGICAL

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

JECEVAX

Eligibility Criteria

• Age: 9 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Hygiene and Epidemiology, Vietnam: lead
• Ministry of Science and Technology, Vietnam: collaborator
• Ministry of Health, Vietnam: collaborator

Study Sites (4)

Hoa Binh Provincial Preventive Medicine Center

Hòa Bình, Hoa Binh, 350000, Vietnam

Location

Hoa Binh City Health Center

Hòa Bình, Hoa Binh, 35000, Vietnam

Location

District Health Center

Thanh Sơn, Phu Tho, Vietnam

Location

Phu Tho Preventive Medicine Center

Việt Trì, Phu Tho, Vietnam

Location

MeSH Terms

Conditions

Encephalitis, Japanese

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Mosquito-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Study Officials

• Thiem D Vu, MD., PhD.

  National Institute of Hygiene and Epidemiology, Vietnam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Department of Epidemiology

Study Record Dates

• First Submitted: July 1, 2017
• First Posted: September 13, 2017
• Study Start: September 30, 2017
• Primary Completion: February 6, 2018
• Study Completion: April 8, 2018
• Last Updated: September 17, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

VN (4)