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

NCT02367664 | Completed Phase 3

• 1 other identifier: JSVCT015
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Encephalitis

Keywords

Japanese encephalitis; immunogenicity; safety; vaccine

Outcome Measures

Primary Outcomes (2)

• 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

  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

  0-7 days after primary vaccination

Secondary Outcomes (8)

• GMT of JE neutralizing antibody following primary vaccination

  28 days after primary vaccination

• positive seroconversion rate of JE neutralizing antibody following booster vaccination

  28 days after booster vaccination

• positive seroconversion rate of JE neutralizing antibody following primary vaccination

  12 months after primary vaccination

• incidence of unsolicited adverse reactions (including systemic and local adverse reactions) following primary vaccination

  0-28 days after primary vaccination

• incidence of adverse event (AE) following booster vaccination

  0-28 days after booster vaccination

Study Arms (3)

0.5ml experimental vaccine on day 0,7

EXPERIMENTAL

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

Biological: 0.5ml experimental vaccine on day 0,7 Vero cell-derived inactivated Japanese Encephalitis vaccine

0.5ml experimental vaccine on day 0,28

EXPERIMENTAL

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

Biological: 0.5ml experimental vaccine on day 0,28 Vero cell-derived inactivated Japanese Encephalitis vaccine

0.5ml active comparator vaccine on day 0,7

ACTIVE COMPARATOR

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

Biological: 0.5ml active comparator vaccine on day 0,7 inactivated freeze-dried Japanese Encephalitis vaccine(Vero cell)

Interventions

0.5ml experimental vaccine on day 0,7 Vero cell-derived inactivated Japanese Encephalitis vaccine BIOLOGICAL

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

0.5ml experimental vaccine on day 0,7

0.5ml experimental vaccine on day 0,28 Vero cell-derived inactivated Japanese Encephalitis vaccine BIOLOGICAL

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

0.5ml experimental vaccine on day 0,28

0.5ml active comparator vaccine on day 0,7 inactivated freeze-dried Japanese Encephalitis vaccine(Vero cell) BIOLOGICAL

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

0.5ml active comparator vaccine on day 0,7

Eligibility Criteria

• Age: 6 Months - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Had never received any Japanese Encephalitis vaccine
• Subjects' legal guardians are able to understand and sign the informed consent
• Subjects and legal guardians can and will comply with the requirements of the protocol
• Subjects with temperature \<=37.0°C on axillary setting

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead
• Shandong Hengye Biotech Co., Ltd.: collaborator

Study Sites (1)

Pizhou Center for Disease Control and Prevention

Xuzhou, Jiangsu, 221300, China

Location

MeSH Terms

Conditions

Encephalitis; Encephalitis, Japanese

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases; 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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: February 20, 2015
• Study Start: October 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 1, 2016

Record last verified: 2015-08

Locations

CN (1)