Japanese EncephalitisPhase 2NCT00621764

Immunogenicity and Safety of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children

A Phase 2 study testing Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28) and Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28) in people with Japanese Encephalitis and Hepatitis A, run by Sanofi Pasteur, a Sanofi Company at 3 sites in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Safety: To describe the safety profiles following vaccination. Immunogenicity: To describe the immune response after a single dose of vaccine. Read more about this study

Who is it for?: Ages 12 months to 5 yearsHealthy volunteers can take part
Conditions the study is for: Japanese Encephalitis, Hepatitis A
What is being tested?: Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28) and Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 3 sitesThailand
Study dates: Mar 2008to May 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 months to 5 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Provision of consent form signed by at least one parent or another legally acceptable representative, and by at least one independent witness.
Completion of vaccinations according to the national immunization schedule
Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
Previous receipt of two doses of a mouse-brain-derived JE vaccine at 12 to 15 months of age according to the national immunization schedule and aged 2 to 5 years on the day of inclusion.
Aged 12 to 24 months on the day of inclusion and have not received any JE vaccine.

Who cannot join

Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances.
Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response.
Receipt of hepatitis A vaccine.

Show all 19Show fewer

History of flavivirus infection (confirmed either clinically, serologically or microbiologically).
Administration of any anti-viral within 2 months preceding the screening visit.
History of central nervous system disorder or disease.
Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
Planned participation in another clinical trial during the present trial period.
Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
Personal human immunodeficiency virus, hepatitis B or hepatitis C seropositivity in the blood sample taken at screening.
Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination.
Previous vaccination against flavivirus disease at any time before the trial other than a mouse-brain-derived JE vaccine given in a two-dose regimen at 12 to 15 months of age in accordance with the national immunization schedule.
Febrile illness or any acute illness/infection on the day of vaccination, according to investigator judgment
History of seizures.
Previous vaccination against flavivirus disease.

Trial locations and contacts

3 sites in 1 country.

Thailand3 sites

Study site
Bangkok, 10330
Study site
Bangkok, 10400
Study site
Bangkok, 10700

Other trials in Thailand

About this study

Official title: A Controlled Study of the Safety and Immunogenicity of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children

Safety:

To describe the safety profiles following vaccination.

Immunogenicity:

To describe the immune response after a single dose of vaccine.

Read the detailed description

This is a randomized, cross-over, open, active controlled, multi-center trial in toddlers and children in Thailand. Stepwise enrollment of children in 2 age cohorts. Subjects will be followed for 5 years.

Conditions: Japanese Encephalitis, Hepatitis A
Being tested: Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28), Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)
Keywords: Japanese encephalitis (JE), Hepatitis A, Inactivated Mouse-Brain
Medical subject headings: Encephalitis, Japanese, Hepatitis A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)Biological
Also called ChimeriVax™-JE
≥4.0 Log10 Plaque forming units (PFU), Subcutaneous (SC; Day 0); 0.5 mL intramuscular (IM; Day 28)
Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)Biological
Also called ChimeriVax™-JE
0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)
Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)Biological
Also called ChimeriVax™-JE
≥4.0 Log10 PFU SC (Day 0); 0.5 mL IM (Day 28)
Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)Biological
Also called ChimeriVax™-JE
0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)

Study groups in NCT00621764
Study group	Role	What they receive
JE-CV/Hepatitis A (Group 1)	Experimental	Participants aged 2 to 5 years at enrollment; to receive Japanese encephalitis vaccine (Day 0) and Hepatitis A vaccine (Day 28) Receives: Biological: Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)
Hepatitis A/JE-CV (Group 2)	Experimental	Participants aged 2 to 5 years at enrollment; to receive Hepatitis A vaccine (Day 0) and Japanese encephalitis vaccine (Day 28) Receives: Biological: Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)
JE-CV/Hepatitis A (Group 3)	Experimental	Participants aged 12 to 24 months at enrollment; to receive Japanese encephalitis vaccine (Day 0) and Hepatitis A vaccine (Day 28) Receives: Biological: Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)
Hepatitis A/JE-CV (Group 4)	Experimental	Participants aged 12 to 24 months at enrollment; to receive Hepatitis A vaccine (Day 0) and Japanese encephalitis vaccine (Day 28) Receives: Biological: Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection
12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, >39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, >3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable.
2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, >39˚C; Headache, Malaise, and Myalgia, Prevents activities.
Measured: Day 0 up to Day 14 post-vaccination
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection
12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, >39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, >3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable.
2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, >39˚C; Headache, Malaise, and Myalgia, Prevents activities.
Measured: Day 0 up to Day 14 post-vaccination

Secondary outcomes (2)

Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination
JE virus neutralizing antibody measurement was assessed by plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer < 10 (1/dil) and post-vaccination titer ≥ 10 (1/dil), or participants with pre-vaccination titer ≥ 10 (1/dil) and 4-fold increase from pre- to post-vaccination.
Measured: Day 0 (pre-vaccination) and Day 28 after final vaccination
Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination
JE virus neutralizing antibody measurement was assessed by the PRNT50 assay.
Measured: Day 0 (pre-vaccination) and Day 28 after final vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008May 2013

First posted22 Feb 2008 (estimated)
Study startMar 2008
Primary completionDec 2009
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Japanese EncephalitisStudies of the same condition, open and under way.
More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00621764
Sponsor's protocol ID: JEC01
Status last verified: Sep 2014
First submitted: 12 Feb 2008
Last updated: 2 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Chokephaibulkit K, Sirivichayakul C, Thisyakorn U, Sabchareon A, Pancharoen C, Bouckenooghe A, Gailhardou S, Boaz M, Feroldi E. Safety and immunogenicity of a single administration of live-attenuated Japanese encephalitis vaccine in previously primed 2- to 5-year-olds and naive 12- to 24-month-olds: multicenter randomized controlled trial. Pediatr Infect Dis J. 2010 Dec;29(12):1111-7. doi: 10.1097/INF.0b013e3181f68e9c.
PubMed 20856164
Feroldi E, Boaz M, Yoksan S, Chokephaibulkit K, Thisyakorn U, Pancharoen C, Monfredo C, Bouckenooghe A. Persistence of Wild-Type Japanese Encephalitis Virus Strains Cross-Neutralization 5 Years After JE-CV Immunization. J Infect Dis. 2017 Jan 15;215(2):221-227. doi: 10.1093/infdis/jiw533.
PubMed 27815383
Chokephaibulkit K, Sirivichayakul C, Thisyakorn U, Pancharoen C, Boaz M, Bouckenooghe A, Feroldi E. Long-term follow-up of Japanese encephalitis chimeric virus vaccine: Immune responses in children. Vaccine. 2016 Nov 4;34(46):5664-5669. doi: 10.1016/j.vaccine.2016.09.018. Epub 2016 Sep 27.
PubMed 27686833

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 4
Immunogenicity, Safety, and Antibody Persistence of Different Immunization Strategies Against Japanese Encephalitis
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RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
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Not yet recruitingObservational study
Diagnostics and Surveillance of Acute Meningo-encephalitis Among Children in Cambodia With a Focus on Japanese Encephalitis Virus
Japanese Encephalitis
Active, not recruitingPhase 4
Monitoring JE Antibody Levels in Healthy Populations and Immunization Strategy in Low-Prevalence Areas
Japanese Encephalitis

All Japanese Encephalitis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Controlled Study of the Safety and Immunogenicity of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children
ClinicalTrials.gov ID: NCT00621764
Acronym / sponsor ID: JEC01
Conditions: Japanese Encephalitis, Hepatitis A
Keywords: Japanese encephalitis (JE), Hepatitis A, Inactivated Mouse-Brain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: Dec 2009 (actual)
Study completion: May 2013 (actual)
First posted: 22 Feb 2008 (estimated)
Results: Posted 25 Sep 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Safety:

To describe the safety profiles following vaccination.

Immunogenicity:

To describe the immune response after a single dose of vaccine.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
JE-CV/Hepatitis A (Group 1)	Experimental	Biological: Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)Participants aged 2 to 5 years at enrollment; to receive Japanese encephalitis vaccine (Day 0) and Hepatitis A vaccine (Day 28)
Hepatitis A/JE-CV (Group 2)	Experimental	Biological: Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)Participants aged 2 to 5 years at enrollment; to receive Hepatitis A vaccine (Day 0) and Japanese encephalitis vaccine (Day 28)
JE-CV/Hepatitis A (Group 3)	Experimental	Biological: Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)Participants aged 12 to 24 months at enrollment; to receive Japanese encephalitis vaccine (Day 0) and Hepatitis A vaccine (Day 28)
Hepatitis A/JE-CV (Group 4)	Experimental	Biological: Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)Participants aged 12 to 24 months at enrollment; to receive Hepatitis A vaccine (Day 0) and Japanese encephalitis vaccine (Day 28)

Who may qualify

Ages: 12 months to 5 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Provision of consent form signed by at least one parent or another legally acceptable representative, and by at least one independent witness.
Completion of vaccinations according to the national immunization schedule
Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
Previous receipt of two doses of a mouse-brain-derived JE vaccine at 12 to 15 months of age according to the national immunization schedule and aged 2 to 5 years on the day of inclusion.
Aged 12 to 24 months on the day of inclusion and have not received any JE vaccine.

Key exclusion criteria (19 listed)

Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances.
Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)Also: ChimeriVax™-JE≥4.0 Log10 Plaque forming units (PFU), Subcutaneous (SC; Day 0); 0.5 mL intramuscular (IM; Day 28)	Biological	JE-CV/Hepatitis A (Group 1)
Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)Also: ChimeriVax™-JE0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)	Biological	Hepatitis A/JE-CV (Group 2)
Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)Also: ChimeriVax™-JE≥4.0 Log10 PFU SC (Day 0); 0.5 mL IM (Day 28)	Biological	JE-CV/Hepatitis A (Group 3)
Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)Also: ChimeriVax™-JE0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)	Biological	Hepatitis A/JE-CV (Group 4)

Primary outcome

Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection
Time frame: Day 0 up to Day 14 post-vaccination
12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, >39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, >3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable. 2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, >39˚C; Headache, Malaise, and Myalgia, Prevents activities.
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection
Time frame: Day 0 up to Day 14 post-vaccination
12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, >39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, >3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable. 2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, >39˚C; Headache, Malaise, and Myalgia, Prevents activities.

2 secondary outcomes

Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination
Time frame: Day 0 (pre-vaccination) and Day 28 after final vaccination
Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination
Time frame: Day 0 (pre-vaccination) and Day 28 after final vaccination

Results and safety

Results posted to the registry on 25 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
JE-CV/Hepatitis A (Group 1)	50	50
Hepatitis A/JE-CV (Group 2)	50	50
JE-CV/Hepatitis A (Group 3)	101	101
Hepatitis A/JE-CV (Group 4)	99	98

Primary outcome: Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection

Time frame: Day 0 up to Day 14 post-vaccination. Number. Unit: Participants

Measure	JE-CV/Hepatitis A (Group 1) n = 50	Hepatitis A/JE-CV (Group 2) n = 50	JE-CV/Hepatitis A (Group 3) n = 101	Hepatitis A/JE-CV (Group 4) n = 99
Injection site Pain (N=50,50,0,0)	15	13 (0 to 0)	NA (0 to 0)	NA (0 to 0)
Grade 3 Injection site Pain (N=50,50,0,0)	0	0 (0 to 0)	NA (0 to 0)	NA (0 to 0)
Injection site Tenderness (N=0,0,101,99)	NA	NA (0 to 0)	43 (0 to 0)	19 (0 to 0)
Grade 3 Injection site Tenderness (N=0,0,101,99)	NA	NA (0 to 0)	0 (0 to 0)	0 (0 to 0)
Injection site Erythema (N=50,50,101,99)	7	9 (0 to 0)	23 (0 to 0)	16 (0 to 0)
Grade 3 Injection site Erythema (N=50,50,101,99)	0	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
Injection site Swelling (N=50,50,101,99)	4	5 (0 to 0)	6 (0 to 0)	8 (0 to 0)
Grade 3 Swelling (N=50,50,101,99)	0	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)

Population analysed: Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.

Primary outcome: Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection

Time frame: Day 0 up to Day 14 post-vaccination. Number. Unit: Participants

Measure	JE-CV/Hepatitis A (Group 1) n = 48	Hepatitis A/JE-CV (Group 2) n = 51	JE-CV/Hepatitis A (Group 3) n = 101	Hepatitis A/JE-CV (Group 4) n = 98
Injection site Pain (N=48,51,0,0)	15	9	NA	NA
Grade 3 Injection site Pain (N=48,51,0,0)	0	0	NA	NA
Injection site Tenderness (N=0,0,100,98)	NA	NA	35	20
Grade 3 Injection site Tenderness (N=0,0,100,98)	NA	NA	1	0
Injection site Erythema (N=48,51,100,98)	8	7	23	22
Grade 3 Injection site Erythema (N=48,51,100,98)	0	0	0	0
Injection site Swelling (N=48,51,100,98)	8	4	6	11
Grade 3 Swelling (N=48,51,100,98)	0	0	0	0

Population analysed: Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine. A participant in Group 1 was given JE-CV vaccine as the second vaccination in error; and counted for Group 2 for the safety outcome for the second injection.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
JE CV/Hepatitis A (Group 1)	3 of 50 (6%)	15 of 50 (30%)	Not reported
Hepatitis A/JE CV (Group 2)	3 of 50 (6%)	18 of 50 (36%)	Not reported
JE CV/Hepatitis A (Group 3)	11 of 101 (10.9%)	43 of 101 (42.6%)	Not reported
Hepatitis A/JE CV (Group 4)	10 of 99 (10.1%)	35 of 99 (35.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20856164Chokephaibulkit K, Sirivichayakul C, Thisyakorn U, Sabchareon A, Pancharoen C, Bouckenooghe A, Gailhardou S, Boaz M, Feroldi E. Safety and immunogenicity of a single administration of live-attenuated Japanese encephalitis vaccine in previously primed 2- to 5-year-olds and naive 12- to 24-month-olds: multicenter randomized controlled trial. Pediatr Infect Dis J. 2010 Dec;29(12):1111-7. doi: 10.1097/INF.0b013e3181f68e9c.
Derived from this study: PubMed 27815383Feroldi E, Boaz M, Yoksan S, Chokephaibulkit K, Thisyakorn U, Pancharoen C, Monfredo C, Bouckenooghe A. Persistence of Wild-Type Japanese Encephalitis Virus Strains Cross-Neutralization 5 Years After JE-CV Immunization. J Infect Dis. 2017 Jan 15;215(2):221-227. doi: 10.1093/infdis/jiw533.
Derived from this study: PubMed 27686833Chokephaibulkit K, Sirivichayakul C, Thisyakorn U, Pancharoen C, Boaz M, Bouckenooghe A, Feroldi E. Long-term follow-up of Japanese encephalitis chimeric virus vaccine: Immune responses in children. Vaccine. 2016 Nov 4;34(46):5664-5669. doi: 10.1016/j.vaccine.2016.09.018. Epub 2016 Sep 27.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Sanofi Pasteur SA

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection (time frame: Day 0 up to Day 14 post-vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00621764, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2014.