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A Clinical Trial for Inactivated Japanese Encephalitis Vaccine in Healthy Chinese Infants

Primary Purpose

Encephalitis

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
0.5ml experimental vaccine on day 0,7 Vero cell-derived inactivated Japanese Encephalitis vaccine
0.5ml experimental vaccine on day 0,28 Vero cell-derived inactivated Japanese Encephalitis vaccine
0.5ml active comparator vaccine on day 0,7 inactivated freeze-dried Japanese Encephalitis vaccine(Vero cell)
Sponsored by
Jiangsu Province Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Encephalitis focused on measuring Japanese encephalitis, immunogenicity, safety, vaccine

Eligibility Criteria

6 Months - 11 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged from 6 to 11 months old on the day of inclusion
  • Had never received any Japanese Encephalitis vaccine
  • Subjects' legal guardians are able to understand and sign the informed consent
  • In good general health judged from medical history and clinical examination at the time of inclusion
  • Subjects and legal guardians can and will comply with the requirements of the protocol
  • Subjects with temperature <=37.0°C on axillary setting

Exclusion Criteria:

  • Subject who has a medical or family history of any of the following: allergic history, seizure, epilepsy, brain or mental disease
  • Subject who is allergic to any ingredient of the vaccine
  • Family history of congenital or hereditary immunodeficiency
  • Subject with damaged or low immune function which has already been known
  • Subject who had a Japanese Encephalitis medical history
  • Subject with acute febrile illness or infectious disease
  • Major congenital defects or serious chronic illness, including perinatal brain damage
  • Thrombocytopenia, blood coagulation disorder or bleeding difficulties with intramuscular injection
  • Subject who has serious allergic history
  • Subject with other medical history not suitable for vaccination such as fainting during injection or acupuncture treatment
  • Any prior administration of immunodepressant or corticosteroids in last 6 months
  • Any prior administration of blood products in last 3 months
  • Any prior administration of other research medicine/vaccine in last 30 days
  • Any prior administration of any attenuated live vaccine in last 30 days
  • Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
  • Any acute infection or serious infection needing systemic antibiotics or antiviral treatment in last 7 days
  • Any fever with temperature >=38.0°C on axillary setting in last 3 days
  • Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent

Sites / Locations

  • Pizhou Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

0.5ml experimental vaccine on day 0,7

0.5ml experimental vaccine on day 0,28

0.5ml active comparator vaccine on day 0,7

Arm Description

0.5ml experimental vaccine on day 0,7 and a booster dose 12 months later

0.5ml experimental vaccine on day 0,28 and a booster dose 12 months later

0.5ml active comparator vaccine on day 0,7 and a booster dose 12 months later

Outcomes

Primary Outcome Measures

positive seroconversion rate of JE neutralizing antibody following primary vaccination
to evaluate the positive seroconversion rate of JE neutralizing antibody 28 days after primary vaccination
incidence of solicited adverse reactions (including systemic and local adverse reactions) following primary vaccination
to evaluate incidence of solicited adverse reactions (including systemic and local adverse reactions) within 0-7 days after primary vaccination

Secondary Outcome Measures

GMT of JE neutralizing antibody following primary vaccination
to evaluate the GMT of JE neutralizing antibody 28 days after primary vaccination
positive seroconversion rate of JE neutralizing antibody following booster vaccination
to evaluate the positive seroconversion rate of JE neutralizing antibody 28 days after booster vaccination
positive seroconversion rate of JE neutralizing antibody following primary vaccination
to evaluate the positive seroconversion rate of JE neutralizing antibody 12 months after primary vaccination
incidence of unsolicited adverse reactions (including systemic and local adverse reactions) following primary vaccination
to evaluate incidence of unsolicited adverse reactions (including systemic and local adverse reactions) within 0-28 days after primary vaccination
incidence of adverse event (AE) following booster vaccination
to evaluate incidence of adverse event (AE) within 0-28 days after booster vaccination
incidence of serious adverse event (SAE) during the whole study period
to evaluate incidence of serious adverse event (SAE) during the whole study period
GMT of JE neutralizing antibody following booster vaccination
to evaluate the GMT and GMI of JE neutralizing antibody 28 days after booster vaccination
GMT of JE neutralizing antibody following primary vaccination
to evaluate the GMT of JE neutralizing antibody 12 months after primary vaccination

Full Information

First Posted
February 2, 2015
Last Updated
August 30, 2016
Sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborators
Shandong Hengye Biotech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02367664
Brief Title
A Clinical Trial for Inactivated Japanese Encephalitis Vaccine in Healthy Chinese Infants
Official Title
A Single-centre Phase III Clinical Trial for Vero Cell-derived Inactivated Japanese Encephalitis Vaccine Produced by Shandong Hengye Biotech Co., Ltd. in Healthy Chinese Infants Aged 6-11 Months, Aimed to Evaluate Immunogenicity and Safety
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborators
Shandong Hengye Biotech Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Japanese encephalitis (JE) is an acute viral zoonotic disease. Neurologic manifestations of the disease range from subtle changes in behavior to serious problems, including blindness, ataxia, weakness, and movement disorders. The Japanese encephalitis virus (JEV) occurs primarily in Southeast Asian. It is spread by culicine mosquitoes, most often Culex tritaeniorhynchus. Its incubation period is 5 to 15 days.In China, JE epidemic peak season is from June to August and it mainly occurred in children. JE has ranked in top ten infectious diseases according to either incidence or mortality. JE vaccines are used to protect the population especially young children and infants from encephalitis diseases. Live attenuated JE vaccines are now widely used. They are directly produced from attenuated virus which may increase the possibility of virulence reversion. Many developed countries are using purified model inactivated JE vaccine. Therefore, it is an inevitable trend in China to develop a new generation of safer and more effective inactivated vaccine to prevent and control epidemic encephalitis.
Detailed Description
Japanese encephalitis (JE) is an acute viral zoonotic disease. Neurologic manifestations of the disease range from subtle changes in behavior to serious problems, including blindness, ataxia, weakness, and movement disorders. The Japanese encephalitis virus (JEV) occurs primarily in Southeast Asian. It is spread by culicine mosquitoes, most often Culex tritaeniorhynchus. Its incubation period is 5 to 15 days. In China, JE epidemic peak season is from June to August and it mainly occurred in children. JE has ranked in top ten infectious diseases according to either incidence or mortality. JE vaccines are used to protect the population especially young children and infants from encephalitis diseases. Live attenuated JE vaccines are now widely used. They are directly produced from attenuated virus which may increase the possibility of virulence reversion. Many developed countries are using purified model inactivated JE vaccine. Therefore, it is an inevitable trend in China to develop a new generation of safer and more effective inactivated vaccine to prevent and control epidemic encephalitis. In order to evaluate immunogenicity and safety of Vero cell-derived inactivated Japanese Encephalitis vaccine produced by Shandong Hengye Biotech Co., Ltd. a single-centre phase III clinical trial is planned to conduct in healthy infants aged 6-11 months in China. There will be two immunization programs. 600 healthy infants aged 6-11 months will be randomly assigned (1:1) to receive an experimental vaccine or a positive control vaccine at day 0,7. Another 300 healthy infants aged 6-11 months will be recruited to receive an experimental vaccine at day 0,28. All of them will be received a third dose as booster vaccination 12 months later.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Encephalitis
Keywords
Japanese encephalitis, immunogenicity, safety, vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
900 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.5ml experimental vaccine on day 0,7
Arm Type
Experimental
Arm Description
0.5ml experimental vaccine on day 0,7 and a booster dose 12 months later
Arm Title
0.5ml experimental vaccine on day 0,28
Arm Type
Experimental
Arm Description
0.5ml experimental vaccine on day 0,28 and a booster dose 12 months later
Arm Title
0.5ml active comparator vaccine on day 0,7
Arm Type
Active Comparator
Arm Description
0.5ml active comparator vaccine on day 0,7 and a booster dose 12 months later
Intervention Type
Biological
Intervention Name(s)
0.5ml experimental vaccine on day 0,7 Vero cell-derived inactivated Japanese Encephalitis vaccine
Intervention Description
Vero cell-derived inactivated Japanese Encephalitis vaccine produced by Shandong Hengye Biotech Co., Ltd./0.5ml, two doses with 7 days interval, a booster dose 12 months after the first dose
Intervention Type
Biological
Intervention Name(s)
0.5ml experimental vaccine on day 0,28 Vero cell-derived inactivated Japanese Encephalitis vaccine
Intervention Description
Vero cell-derived inactivated Japanese Encephalitis vaccine produced by Shandong Hengye Biotech Co., Ltd./0.5ml, two doses with 28 days interval, a booster dose 12 months after the first dose
Intervention Type
Biological
Intervention Name(s)
0.5ml active comparator vaccine on day 0,7 inactivated freeze-dried Japanese Encephalitis vaccine(Vero cell)
Intervention Description
inactivated freeze-dried Japanese Encephalitis vaccine(Vero cell) produced by Beijing Tiantan Biological Products Co., Ltd. /0.5ml, two doses with 7 days interval, a booster dose 12 months after the first dose
Primary Outcome Measure Information:
Title
positive seroconversion rate of JE neutralizing antibody following primary vaccination
Description
to evaluate the positive seroconversion rate of JE neutralizing antibody 28 days after primary vaccination
Time Frame
28 days after primary vaccination
Title
incidence of solicited adverse reactions (including systemic and local adverse reactions) following primary vaccination
Description
to evaluate incidence of solicited adverse reactions (including systemic and local adverse reactions) within 0-7 days after primary vaccination
Time Frame
0-7 days after primary vaccination
Secondary Outcome Measure Information:
Title
GMT of JE neutralizing antibody following primary vaccination
Description
to evaluate the GMT of JE neutralizing antibody 28 days after primary vaccination
Time Frame
28 days after primary vaccination
Title
positive seroconversion rate of JE neutralizing antibody following booster vaccination
Description
to evaluate the positive seroconversion rate of JE neutralizing antibody 28 days after booster vaccination
Time Frame
28 days after booster vaccination
Title
positive seroconversion rate of JE neutralizing antibody following primary vaccination
Description
to evaluate the positive seroconversion rate of JE neutralizing antibody 12 months after primary vaccination
Time Frame
12 months after primary vaccination
Title
incidence of unsolicited adverse reactions (including systemic and local adverse reactions) following primary vaccination
Description
to evaluate incidence of unsolicited adverse reactions (including systemic and local adverse reactions) within 0-28 days after primary vaccination
Time Frame
0-28 days after primary vaccination
Title
incidence of adverse event (AE) following booster vaccination
Description
to evaluate incidence of adverse event (AE) within 0-28 days after booster vaccination
Time Frame
0-28 days after booster vaccination
Title
incidence of serious adverse event (SAE) during the whole study period
Description
to evaluate incidence of serious adverse event (SAE) during the whole study period
Time Frame
Day 0 of the first dose up to Day 28 of the third dose
Title
GMT of JE neutralizing antibody following booster vaccination
Description
to evaluate the GMT and GMI of JE neutralizing antibody 28 days after booster vaccination
Time Frame
28 days after booster vaccination
Title
GMT of JE neutralizing antibody following primary vaccination
Description
to evaluate the GMT of JE neutralizing antibody 12 months after primary vaccination
Time Frame
12 months after primary vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
11 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged from 6 to 11 months old on the day of inclusion Had never received any Japanese Encephalitis vaccine Subjects' legal guardians are able to understand and sign the informed consent In good general health judged from medical history and clinical examination at the time of inclusion Subjects and legal guardians can and will comply with the requirements of the protocol Subjects with temperature <=37.0°C on axillary setting Exclusion Criteria: Subject who has a medical or family history of any of the following: allergic history, seizure, epilepsy, brain or mental disease Subject who is allergic to any ingredient of the vaccine Family history of congenital or hereditary immunodeficiency Subject with damaged or low immune function which has already been known Subject who had a Japanese Encephalitis medical history Subject with acute febrile illness or infectious disease Major congenital defects or serious chronic illness, including perinatal brain damage Thrombocytopenia, blood coagulation disorder or bleeding difficulties with intramuscular injection Subject who has serious allergic history Subject with other medical history not suitable for vaccination such as fainting during injection or acupuncture treatment Any prior administration of immunodepressant or corticosteroids in last 6 months Any prior administration of blood products in last 3 months Any prior administration of other research medicine/vaccine in last 30 days Any prior administration of any attenuated live vaccine in last 30 days Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine Any acute infection or serious infection needing systemic antibiotics or antiviral treatment in last 7 days Any fever with temperature >=38.0°C on axillary setting in last 3 days Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent
Facility Information:
Facility Name
Pizhou Center for Disease Control and Prevention
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221300
Country
China

12. IPD Sharing Statement

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A Clinical Trial for Inactivated Japanese Encephalitis Vaccine in Healthy Chinese Infants

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